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Product-Specific Guidances for Generic Drug Development

To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use; bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its RLD.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence (BE) for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate BE depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct BE testing using the most accurate, sensitive, and reproducible approach available among those set forth in 21 CFR 320.24. As the initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).

To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances (PSGs) describing the Agency's current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific RLD.

FDA publishes these PSGs to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs

These guidances are published in an incremental manner and listed below in alphabetical order according to the active ingredient's name. The most recently published guidances (new and revised) are listed below.

Additionally, as part of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 20221 (GDUFA III). FDA will issue PSGs consistent with the following goals:

  • For complex products1,2 approved in new drug applications (NDAs) on or after October 1, 2022, a PSG will be issued for 50 percent of such NDA products within 2 years after the date of approval, and for 75 percent of such NDA products within 3 years after the date of approval.
  • FDA will continue to develop PSGs for complex products approved prior to October 1, 2022, for which no PSG has been published.
  • For non-complex drug products approved in NDAs on or after October 1, 2022, that contain a new chemical entity (NCE) (as described in section 505(j)(5)(F)(ii) of the FD&C Act), a PSG will be issued within 2 years after the date of approval for 90 percent of such products.
In addition to its GDUFA III commitments, FDA will prioritize publishing of PSGs based on public health priorities, drug availability and accessibility, public requests for guidance, stakeholder interest in ANDA submission.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or BE and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct; including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring.

Some of the PSGs include discussion regarding data formats. Please note that under section 745A(a) of the Federal Food, Drug, and Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified must be used for submissions to ANDAs. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at esub@fda.hhs.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

COMMENTS: The Agency is seeking feedback and considers comments to the docket on these guidances. You may submit comments on any guidance at any time as follows: Submit electronic comments to Docket FDA-2007-D-0369. For further information on submitting electronic comments, refer to (www.regulations.gov). You may also mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions received must include the Docket No. [FDA-2007-D-0369]. Please contact the Regulations.gov Help Desk at 1-877-378-5457 (toll free) or at (www.regulations.gov/support) for assistance regarding submissions.

The FDA posts plans for issuing new or revised PSGs on the Upcoming Product-Specific Guidances for Generic Drug Product Development web page

For additional information on development of generic drug products, please refer to FDA's guidance document database.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III Commitment Letter)

2Classifying Approved New Drug Products and Drug-device combination Products as Complex Products for Generic Drug Development Purposes (CDER MAPP 5240.10)

Total number of currently published PSGs: 2069

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


2069 record(s) found for ''.

Active Ingredient URL (link to Specific Guidance) Type Route Dosage Form RLD or RS Number Date Recommended
Abacavir Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abacavir_Sulfate_tab_20977_RC5-06.pdf Final Oral Tablet 020977 05/01/2008
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205551.pdf Draft Oral Tablet 205551 08/01/2020
Abacavir Sulfate; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abacavir_Sulfate_Lamivudine_tab_21652_RC7-06.pdf Draft Oral Tablet 021652 11/01/2007
Abacavir Sulfate; Lamivudine; Zidovudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abacavir_Lamivudine_Zidovudine_tab_21205_RC9-05.pdf Final Oral Tablet 021205 05/01/2008
Abametapir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206966.pdf Draft Topical Lotion 206966 10/21/2022
Abemaciclib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abemaciclib_draft_Oral tab_RLD 208716_RC09-18.pdf Draft Oral Tablet 208716 09/01/2018
Abiraterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abiraterone acetate_oral tablet_NDA 202379_RV07-18.pdf Draft Oral Tablet 202379 07/01/2018
Abiraterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210308.pdf Draft Oral Tablet 210308 06/01/2020
Acalabrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acalabrutinib Oral Capsules NDA 210259 RC Feb 2019.pdf Draft Oral Capsule 210259 02/01/2019
Acamprosate Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acamprosate calcium_oral DR tablet_RLD 21431 and 202229_RV03-17.pdf Draft Oral Tablet, Delayed Release 021431 05/01/2017
Acarbose https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020482.pdf Draft Oral Tablet 020482 05/19/2022
Acetaminophen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen_ERtab_19872_RC2-11.pdf Draft Oral Tablet, Extended Release 019872 02/01/2011
Acetaminophen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018337.pdf Draft Rectal Suppository 018337 05/19/2022
Acetaminophen; Aspirin; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Aspirin; Caffeine_oral tablet_RLD 020802_Final 08-17.pdf Final Oral Tablet 020802 08/01/2017
Acetaminophen; Benzhydrocodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208653.pdf Draft Oral Tablet 208653 11/01/2019
Acetaminophen; Butalbital https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;_Butalbital_cap_88831_88889_RC3-10.pdf Draft Oral Capsule 088831 03/01/2010
Acetaminophen; Butalbital https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen Butalbital Oral Tablet ANDA 89987 RV Feb 2019.pdf Draft Oral Tablet 089987 02/01/2019
Acetaminophen; Butalbital; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;Butalbital;Caffeine_A89007 A0885 A40885_RV Oct 2018.pdf Draft Oral Capsule 040885 089007 11/01/2018
Acetaminophen; Butalbital; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Butalbital; Caffeine_Oraltablet_ANDA 040511_RV Oct 2018.pdf Draft Oral Tablet 040511 11/01/2018
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen ; ButalbitalRLD_020232_Final 08-17.pdf Final Oral Capsule 020232 08/01/2017
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;_Caffeine;_Dihydrocodeine_Bitartrate_tab_40316__40109_RC4-09.pdf Final Oral Tablet 040109 10/01/2011
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Caffeine; Dihydrocodeine Bitartrate Oral Capsule ANDA 204785 RC Feb 2019.pdf Draft Oral Capsule 204785 02/01/2019
Acetaminophen; Codeine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Codeine Phosphate Tablet ANDA 085055 PSG Page RC May 2019.pdf Draft Oral Tablet 085055 05/01/2019
Acetaminophen; Hydrocodone Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen_Hydro_bit 40658; 40556; 40864; 40148; 40099_RV06-16.pdf Draft Oral Tablet 040099 040148 040658 040846 06/01/2016
Acetaminophen; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211733.pdf Draft Oral Tablet 211733 08/02/2022
Acetaminophen; Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen; Oxycodone HCL_oral ER tablet_RLD 204031_RC 09-16.pdf Draft Oral Tablet, Extended Release 204031 10/01/2016
Acetaminophen; Oxycodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;OxycodoneHCL_Oral tablet_ANDA 40330_RV Oct 2018.pdf Draft Oral Tablet 040330 11/01/2018
Acetaminophen; Propoxyphene Napsylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;_Propoxyphene_Napsylate_tab_17122_76429_76743_RC2-10.pdf Draft Oral Tablet 076429 02/01/2010
Acetaminophen; Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tramadol_HCl_Acetaminophen_tab_21123_RC1-06.pdf Final Oral Tablet 021123 05/01/2008
Acetazolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetazolamide_ERcaps_12945_RC2-10.pdf Draft Oral Capsule, Extended Release 012945 02/01/2010
Acetazolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetazolamide Oral Tablet NDA 008943 RV 09-2018.pdf Draft Oral Tablet 008943 09/01/2018
Acetylcysteine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetylcystein_oral effervescent tablet_RLD 207916_RC03-17.pdf Draft Oral Tablet, Effervescent 207916 05/01/2017
Acitretin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acitretin_Oral Capsule_RLD19821_Final 08-17.pdf Final Oral Capsule 019821 08/01/2017
Aclidinium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aclidinium bromide_inhalation powder_202450_RC09-15.pdf Draft Inhalation Powder, Metered 202450 09/01/2015
Aclidinium Bromide; Formoterol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210595.pdf Draft Inhalation Powder, Metered 210595 02/17/2022
Acrivastine; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acrivastine; Pseudoephedrine HCl_draft_Oral cap_RLD 019806_RC07-18.pdf Draft Oral Capsule 019806 07/01/2018
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202408.pdf Draft Ophthalmic Ointment 202408 08/20/2021
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203791.pdf Draft Buccal Tablet 203791 11/17/2022
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_cap_18828_RC03-12.pdf Draft Oral Capsule 018828 03/01/2012
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_tab_20089_RC8-05.pdf Final Oral Tablet 020089 05/01/2008
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021478.pdf Draft Topical Cream 021478 10/21/2022
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018604.pdf Draft Topical Ointment 018604 10/21/2022
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019909.pdf Draft Oral Suspension 019909 09/01/2019
Acyclovir; Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022436.pdf Draft Topical Cream 022436 10/21/2022
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022502.pdf Draft Topical Lotion 022502 11/01/2019
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020748.pdf Draft Topical Cream 020748 11/01/2019
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020380.pdf Draft Topical Gel 020380 10/21/2022
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021753.pdf Draft Topical Gel 021753 10/21/2022
Adapalene; Benzoyl Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022320.pdf Draft Topical Gel 022320 10/21/2022
Adapalene; Benzoyl Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207917.pdf Draft Topical Gel 207917 10/21/2022
Adefovir Dipivoxil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Adefovir_Dipivoxil_tab_21449_RC7-08.pdf Draft Oral Tablet 021449 07/01/2008
Afatinib Dimaleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Afatinib dimaleate_Oral tablet_201292_RC06-15.pdf Draft Oral Tablet 201292 06/01/2015
Albendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Albendazole_Chewble tablet_RLD 207844_RC04-16.pdf Draft Oral Tablet, Chewable 207844 04/01/2016
Albendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020666.pdf Draft Oral Tablet 020666 06/01/2020
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf Draft Inhalation Powder, Metered 205636 03/01/2020
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019604.pdf Draft Oral Tablet, Extended Release 019604 03/01/2020
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf Draft Inhalation Aerosol, Metered 020503 021457 020983 03/01/2020
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Albuterol sulfate_oral tablet_RLD 072894_RV06-16.pdf Draft Oral Tablet 017853 06/01/2016
Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/20/2021
Alcaftadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alcaftadine_ophthalmic solution_NDA 022134_RC11-17.pdf Draft Ophthalmic Solution/Drops 022134 02/01/2018
Alectinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alectinib HCl_oral capsule_RLD 208434_RC09-16.pdf Draft Oral Capsule 208434 10/01/2016
Alendronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alendronate sodium_oral effervescent tablet_202344_RC06-15.pdf Draft Oral Tablet, Effervescent 202344 06/01/2015
Alendronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alendronate__Sodium_tab_20560_RC1-08.pdf Draft Oral Tablet 020560 10/01/2011
Alendronate Sodium; Cholecalciferol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alendronate_Cholecalciferol_tab_21762_RC4-09.pdf Draft Oral Tablet 021762 10/01/2011
Alfuzosin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alfuzosin_ERtab_21287_RC7-04.pdf Draft Oral Tablet, Extended Release 021287 11/01/2007
Aliskiren Hemifumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren_Hemifumarate_tab_21985_RC8-09.pdf Draft Oral Tablet 021985 08/01/2009
Aliskiren Hemifumarate; Amlodipine Besylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren_Hemifumarate; Amlodipine_Besylate_Tab_22545_RC06-12.pdf Draft Oral Tablet 022545 06/01/2012
Aliskiren Hemifumarate; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren;_HCTZ_tab_22107_RC8-09.pdf Draft Oral Tablet 022107 08/01/2009
Aliskiren Hemifumarate; Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren_Hemifumarate;_Valsartan_tab_22217_RC03-11.pdf Draft Oral Tablet 022217 03/01/2011
Allopurinol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Allopurinol_tab_16084_RC4-09.pdf Draft Oral Tablet 016084 04/01/2009
Allopurinol; Lesinurad https://www.accessdata.fda.gov/drugsatfda_docs/psg/Allopurinol; Lesinurad_draft_Oral tab_RLD 209203_RC09-18.pdf Draft Oral Tablet 209203 09/01/2018
Almotriptan Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Almotriptan_Malate_tab_21001_RC5-05.pdf Final Oral Tablet 021001 05/01/2008
Alogliptin Benzoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alogliptin benzoate_tab_22271_RC07-14.pdf Draft Oral Tablet 022271 07/01/2014
Alogliptin Benzoate; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alogliptin_benzoate_Metformin_HCl_tab_203414 RC07-14.pdf Draft Oral Tablet 203414 07/01/2014
Alogliptin Benzoate; Pioglitazone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alogliptin_benzoate_Pioglitazone_tab_22426_RC07-14.pdf Draft Oral Tablet 022426 07/01/2014
Alosetron Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alosetron_HCl_tab_21107_ RC5-05.pdf Final Oral Tablet 021107 05/01/2008
Alpelisib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212526.pdf Draft Oral Tablet 212526 08/01/2020
Alprazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021726.pdf Draft Oral Tablet, Orally Disintegrating 021726 11/08/2021
Alprazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alprazolam_tab_21434_RC6-04.pdf Draft Oral Tablet, Extended Release 021434 11/01/2007
Alprazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alprazolam_tab_18276_RC3-05.pdf Draft Oral Tablet 018276 09/01/2008
Alprostadil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alprostadil_urethral suppository_RLD 020700_RC01-16.pdf Draft Urethral Suppository 020700 01/01/2016
Altretamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Altretamine_caps_19926_RC04-10.pdf Draft Oral Capsule 019926 04/01/2010
Alvimopan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alvimopan_Cap_21775_RC06-12 .pdf Draft Oral Capsule 021775 06/01/2012
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amamtadine Hydrochloride_Oral Capsule_ 071293_RV09-15.pdf Draft Oral Capsule 016020 09/01/2015
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amantadine_HCl_tab_76186_RC11-10.pdf Draft Oral Tablet 018101 01/01/2011
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209410.pdf Draft Oral Tablet, Extended Release 209410 09/01/2019
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amantadine Hydrochloride Oral Extended Release Capsule NDA 208944 RC 09-2018.pdf Draft Oral Capsule, Extended Release 208944 09/01/2018
Ambrisentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ambrisentan_tab_22081_RV06-13.pdf Draft Oral Tablet 022081 06/01/2013
Amcinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amcinonide_topical lotion_RLD 76329_RC 06-16.pdf Draft Topical Lotion 076329 06/01/2016
Amifampridine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208078.pdf Draft Oral Tablet 208078 03/01/2020
Amiloride Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amiloride_tab_ 70346_RC03-12.pdf Draft Oral Tablet 018200 03/01/2012
Amino Acids;Calcium Chloride;Dextrose;Magnesium Sulfate;Potassium Chloride;Sodium Acetate;Sodium Glycerophosphate;Soybean Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200656.pdf Draft Intravenous Emulsion 200656 03/01/2020
Aminocaproic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aminocaproic acid_oral tablet_015197_RC09-15.pdf Draft Oral Tablet 015197 09/01/2015
Aminosalicylic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aminosalicylic_Acid_DRgran_74346_RC7-08.pdf Draft Oral Granule, Delayed Release 074346 07/01/2008
Amiodarone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amiodarone_HCl_tab_18972_RC12-10.pdf Draft Oral Tablet 018972 12/01/2010
Amisulpride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209510.pdf Draft Intravenous Solution 209510 08/20/2021
Amitriptyline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amitriptyline_HCl_tab_85966_85969_85968_85971_85967_85970_RC3-10.pdf Draft Oral Tablet 085966 085967 085968 085969 085970 085971 03/01/2010
Amitriptyline Hydrochloride; Chlordiazepoxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amitriptyline HCl; Chlordiazepoxide_oral tablet_NDA 16949_RC11-17.pdf Draft Oral Tablet 016949 02/01/2018
Amlodipine Benzoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211340.pdf Draft Oral Suspension 211340 08/01/2020
Amlodipine Besylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate_tab_19787_RC6-03.pdf Final Oral Tablet 019787 05/01/2008
Amlodipine Besylate; Atorvastatin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate;_Atorvastatin_Calcium_tab_21540_RC5-09.pdf Draft Oral Tablet 021540 05/01/2009
Amlodipine Besylate; Benazepril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_benazepril_020364_RV02-14.pdf Draft Oral Capsule 020364 02/01/2014
Amlodipine Besylate; Celecoxib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210045.pdf Draft Oral Tablet 210045 05/01/2021
Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Hydrochlorothiazide_Olmesartin_tab_200175_RC12-12.pdf Draft Oral Tablet 200175 12/01/2012
Amlodipine Besylate; Olmesartan Medoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate;_Olmesartan_Medoxomil_tab_22100_RC10-08.pdf Draft Oral Tablet 022100 10/01/2008
Amlodipine Besylate; Perindopril Arginine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine besylate; Perinopril arginine_ Oral tablet_RLD 205003_RC04-16.pdf Draft Oral Tablet 205003 04/01/2016
Amlodipine Besylate; Telmisartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate;_Telmisartan_tabs_ 22401_RC08-10.pdf Draft Oral Tablet 022401 08/01/2010
Amlodipine Besylate; Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate;_Valsartan_tab_21990_RC8-08.pdf Draft Oral Tablet 021990 08/01/2008
Amlodipine Besylate;Hydrochlorothiazide;Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine;_HCTZ;_Valsartan_tabs_22314_RC04-10.pdf Draft Oral Tablet 022314 04/01/2010
Ammonium Lactate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020508.pdf Draft Topical Cream 020508 11/17/2022
Ammonium Lactate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019155.pdf Draft Topical Lotion 019155 11/17/2022
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050542.pdf Draft Oral Tablet, Chewable 050542 06/01/2020
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Oral Suspension_RLD 50460_final 08-17.pdf Final Oral Suspension 050460 08/01/2017
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Oral Suspension_RLD 065119_Final 08-17.pdf Final Oral Suspension 065119 08/01/2017
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_ERtab_50813_RC04-13.pdf Draft Oral Tablet, Extended Release 050813 04/01/2013
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_cap_061926_RC09-12.pdf Draft Oral Capsule 050459 09/01/2012
Amoxicillin; Clarithromycin; Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050824.pdf Draft Oral Capsule, Tablet, Capsule, Delayed Release 050824 08/01/2020
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Clavulanate_potassium_susp_50575_RC09-12.pdf Draft Oral Suspension 050575 09/01/2012
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin; Clavulanate potassiumand 050564_Final 08-17.pdf Final Oral Tablet 050564 050720 08/01/2017
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Clavu_chew_50597_RC1-08.pdf Draft Oral Tablet, Chewable 050597 01/01/2008
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050726.pdf Draft Oral Tablet, Chewable 050726 08/02/2022
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Clavulanate_Potassium_susp_50755_RC7-05..pdf Final Oral Suspension 050725 050755 05/01/2008
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050785.pdf Draft Oral Tablet, Extended Release 050785 09/01/2019
Amoxicillin; Omeprazole Magnesium; Rifabutin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213004.pdf Draft Oral Capsule, Delayed Release 213004 08/01/2020
Amphetamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_Oral suspension_NDA 204325_PSG Page RC Nov 2018.pdf Draft Oral Suspension, Extended Release 204325 11/01/2018
Amphetamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_oral ER suspension_RLD 208147_RC12-16.pdf Draft Oral Suspension, Extended Release 208147 12/01/2016
Amphetamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_orally disintegrating ER tablet_RLD 204326_RC 03-17.pdf Draft Oral Tablet, Orally Disintegrating, Extended Release 204326 05/01/2017
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_Aspartate_21303_RC09-12.pdf Draft Oral Capsule, Extended Release 021303 09/01/2012
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_aspartate__40422_RV11-13.pdf Draft Oral Tablet 011522 11/01/2013
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate_draft_Oral cap ER_RLD 022063_RC09-18.pdf Draft Oral Capsule, Extended Release 022063 09/01/2018
Amphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine sulfate_oral tablet_ANDA 200166_RC11-17.pdf Draft Oral Tablet 200166 02/01/2018
Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210526.pdf Draft Oral Tablet, Extended Release 210526 08/02/2022
Amphotericin B https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050740.pdf Draft Injection Injectable, Liposomal 050740 08/01/2020
Ampicillin/Ampicillin Trihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_064082.pdf Draft Oral Capsule 064082 08/02/2022
Amprenavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amprenavir_cap_21007_RC8-08.pdf Draft Oral Capsule 021007 08/01/2008
Anagrelide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Anagrelide_HCl_cap_20333_RC5-05.pdf Final Oral Capsule 020333 05/01/2008
Anastrozole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Anastrozole_tab_20541_RC10-05.pdf Final Oral Tablet 020541 05/01/2008
Angiotensin II Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/ANGIOTENSIN II ACETATE IV infusion solution NDA 209360 RC Feb 2019.pdf Draft Intravenous Solution 209360 02/01/2019
Apalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Apalutamide Oral Tablets NDA 210951 PSG Page RC May 2019.pdf Draft Oral Tablet 210951 05/01/2019
Apixaban https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202155.pdf Draft Oral Tablet 202155 02/17/2022
Apomorphine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210875.pdf Draft Sublingual Film 210875 02/17/2022
Apremilast https://www.accessdata.fda.gov/drugsatfda_docs/psg/Apremilast_Oral tablet_205437_RC09-15.pdf Draft Oral Tablet 205437 09/01/2015
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aprepitant_cap_21549_RC10-05.pdf Final Oral Capsule 021549 05/01/2008
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aprepitan_oral for suspension_RLD 207865_RC03-17.pdf Draft Oral Suspension 207865 05/01/2017
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf Draft Intravenous Emulsion 209296 06/01/2020
Aripiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aripiprazole Oral Tablet NDA 021436 RV Feb 2019.pdf Draft Oral Tablet 021436 02/01/2019
Aripiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aripiprazole_ERinjecsusp_202971_RC12-14.pdf Draft Intramuscular For Suspension, Extended Release 202971 12/01/2014
Aripiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021729.pdf Draft Oral Tablet, Orally Disintegrating 021729 11/08/2021
Armodafinil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021875.pdf Draft Oral Tablet 021875 09/01/2019
Arsenic Trioxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021248.pdf Draft Injectable Injection 021248 05/19/2022
Artemether;Lumefantrine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Artemether_lumefantrine_tab_22268_RC06-13.pdf Draft Oral Tablet 022268 06/01/2013
Artesunate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213036.pdf Draft Intravenous Powder 213036 11/08/2021
Asenapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212268.pdf Draft Transdermal System 212268 05/19/2022
Asenapine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Asenapine maleate_Sublingual tablet_NDA 022117_RV Oct 2018.pdf Draft Sublingual Tablet 022117 11/01/2018
Aspirin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin_oral capsule_203697_RC06-15.pdf Draft Oral Capsule 203697 06/01/2015
Aspirin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin_oral ER capsule_NDA 200671_RC05-17.pdf Draft Oral Capsule, Extended Release 200671 07/01/2017
Aspirin; Butalbital; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin; Butalbital; Caffeine_oral capsule_ RLD 017534_Final 08-17.pdf Final Oral Capsule 017534 08/01/2017
Aspirin; Butalbital; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin;_Butalbital;_Caffeine_tab_86162_RC3-10.pdf Final Oral Tablet 017534 08/01/2017
Aspirin; Butalbital; Caffeine; Codeine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin; Butalbital; Caffeine; Codeine Phosphate 19429_Final 08-17.pdf Final Oral Capsule 019429 08/01/2017
Aspirin; Dipyridamole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin;_Dipyridamole_ERcap_20884_RC3-10.pdf Draft Oral Capsule, Extended Release 020884 03/01/2010
Aspirin; Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin; Omeprazole_oral DR tablet_NDA 205103_RV11-17.pdf Draft Oral Tablet, Delayed Release 205103 02/01/2018
Aspirin; Oxycodone Hydrochloride; Aspirin;Oxycodone Terephthalate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin;_Oxycodone_tab_07337_RC2-10.pdf Draft Oral Tablet 007337 02/01/2010
Atazanavir Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atazanavir_Sulfate_cap_21567_RC3-05.pdf Final Oral Capsule 021567 05/01/2008
Atazanavir Sulfate; Cobicistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atazanavir Sulfate and Cobicistat_oral tablet_206353_RC01-16.pdf Draft Oral Tablet 206353 01/01/2016
Atenolol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atenolol_oral tablet_ RLD 18240_Final 08-17.pdf Final Oral Tablet 018240 08/01/2017
Atenolol; Chlorthalidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atenolol; Chlorthalidone_oral tablet_ RLD 18760_Final 08-17.pdf Final Oral Tablet 018760 08/01/2017
Atomoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atomoxetine_HCl_cap_21411_RC11-50.pdf Final Oral Capsule 021411 05/01/2008
Atorvastatin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atorvastatin_tabs_20702_RC5-08.pdf Draft Oral Tablet 020702 10/01/2010
Atorvastatin Calcium;Ezetimibe https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atorvastatin ezetimibe_tab_200153_RC02-14.pdf Draft Oral Tablet 200153 04/01/2014
Atovaquone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atovaquone_susp_20500_RC12-09.pdf Draft Oral Suspension 020500 12/01/2009
Atovaquone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atovaquone_tab_20259_RC5-05.pdf Draft Oral Tablet 020259 11/01/2007
Atovaquone;Proguanil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atovaquone__Proguanil_tab_21078_RC7-08.pdf Draft Oral Tablet 021078 07/01/2008
Atropine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206289.pdf Draft Ophthalmic Solution/Drops 206289 02/17/2022
Atropine Sulfate;Diphenoxylate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atropine Sulfate; DiphenoxylateHCl_NDA 012462RC Nov 2018.pdf Draft Oral Tablet 012462 11/01/2018
Auranofin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Auranofin_cap_18689_RC2-10.pdf Draft Oral Capsule 018689 02/01/2010
Avanafil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Avanafil_oral tab_202276_RC03-15.pdf Draft Oral Tablet 202276 03/01/2015
Avapritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212608.pdf Draft Oral Tablet 212608 08/20/2021
Avatrombopag Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210238.pdf Draft Oral Tablet 210238 09/01/2019
Axitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Axitinib_tab_202324_RC02-14.pdf Draft Oral Tablet 202324 04/01/2014
Azacitidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050794.pdf Draft Intravenous, Subcutaneous Powder 050794 05/01/2021
Azathioprine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azathioprine_tabs_16324_RC09-10.pdf Draft Oral Tablet 016324 09/01/2010
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelaic Acid Cream 20 NDA 020428 PSG Page RV May 2019.pdf Draft Topical Cream 020428 05/01/2019
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelaic Acid Gel 15 NDA 021470 PSG Page RV May 2019.pdf Draft Topical Gel 021470 05/01/2019
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207071.pdf Draft Topical Aerosol, Foam 207071 11/18/2020
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azelastine HCl_nasal metered spray_NDA 022203_RC08-17.pdf Draft Nasal Spray, Metered 022203 10/01/2017
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020114.pdf Draft Nasal Spray, Metered 020114 08/02/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213872.pdf Draft Nasal Spray, Metered 213872 08/02/2022
Azelastine Hydrochloride; Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202236.PDF Draft Nasal Spray, Metered 202236 06/01/2020
Azilsartan Kamedoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azilsartan_Medoxomil_Tab_200796_RC06-12.pdf Draft Oral Tablet 200796 06/01/2012
Azilsartan Kamedoxomil; Chlorthalidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azilsartan_Kamedoxomil_Chlorthalidone_Tab_202331_RC03-15.pdf Draft Oral Tablet 202331 03/01/2015
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_oral for suspension_NDA 050693_RC08-17.pdf Draft Oral For Suspension 050693 10/01/2017
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_susp_50693_50710_RC12-08.pdf Draft Oral For Suspension 050710 12/01/2008
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_ERsusp_50797_RC7-08 .pdf Draft Oral Suspension, Extended Release 050797 07/01/2008
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_tab_50730_RC1-08.pdf Draft Oral Tablet 050711 050730 050784 01/01/2008
Bacitracin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bacitracin_ophthalmic ointment_RLD61212_RV09-16.pdf Draft Ophthalmic Ointment 061212 10/01/2016
Baclofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021589.pdf Draft Oral Tablet, Orally Disintegrating 021589 11/01/2019
Baclofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Baclofen_tab_72235_72234_RC2-10.pdf Draft Oral Tablet 017851 02/01/2010
Baloxavir Marboxil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210854.pdf Draft Oral Tablet 210854 09/01/2019
Balsalazide Disodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Balsalazide_disodium_tab_022205_RC06-13.pdf Draft Oral Tablet 022205 06/01/2013
Balsalazide Disodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Balsalazide_cap_20610_RC1-08.pdf Draft Oral Capsule 020610 01/01/2008
Baricitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207924.pdf Draft Oral Tablet 207924 11/17/2022
Barium Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Barium sulfate_oral paste_NDA 208844_RC08-17.pdf Draft Oral Paste 208844 10/01/2017
Barium Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Barium sulfate_oral supension_NDA 208036_RC11-17.pdf Draft Oral Suspension 208036 02/01/2018
Barium Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Barium sulfate_oral supension_NDA 208143_RC11-17.pdf Draft Oral Suspension 208143 02/01/2018
Beclomethasone Dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020911.pdf Draft Inhalation Aerosol, Metered 020911 03/01/2020
Beclomethasone Dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Beclomethasone dipropionate Inhalation Aerosol Metered NDA 207921 PSG Page RC May 2019.pdf Draft Inhalation Aerosol, Metered 207921 05/01/2019
Beclomethasone Dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Beclomethasone dipropionate_draft_Nasal aerosol metered_RLD 202813_RC07-18.pdf Draft Nasal Aerosol, Metered 202813 07/01/2018
Beclomethasone Dipropionate Monohydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019389.pdf Draft Nasal Spray, Metered 019389 11/08/2021
Bedaquiline Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bedaquiline_fumarate_tab_204384_RC11-13.pdf Draft Oral Tablet 204384 11/01/2013
Bempedoic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211616.pdf Draft Oral Tablet 211616 11/08/2021
Bempedoic Acid; Ezetimibe https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211617.pdf Draft Oral Tablet 211617 11/08/2021
Benazepril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benazepril_HCl_tabs_19851_RC07-10.pdf Draft Oral Tablet 019851 07/01/2010
Benazepril Hydrochloride; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benazepril HCL and hydrochlorothiazide_oral tablet_20033_RC09-15.pdf Draft Oral Tablet 020033 09/01/2015
Benoxinate hydrochloride; Fluorescein sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benoxinate hydrochloride; Fluorescein sodium Ophthalmic solution drops 0.25-0.45 NDA 208582 PSG Page RC May 2019.pdf Draft Topical Solution/Drops 208582 05/01/2019
Benznidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Beznidazole Oral Tablets NDA 209570 RC 09-2018.pdf Draft Oral Tablet 209570 09/01/2018
Benzonatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzonatate _oral capsule_040749 040627 201209_RV09-15.pdf Draft Oral Capsule 011210 09/01/2015
Benzoyl Peroxide; Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050819.pdf Draft Topical Gel 050819 11/01/2019
Benzoyl Peroxide; Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050741.pdf Draft Topical Gel 050741 11/01/2019
Benzoyl Peroxide; Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050756.pdf Draft Topical Gel 050756 11/01/2019
Benzoyl Peroxide; Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050557.pdf Draft Topical Gel 050557 11/01/2019
Benzoyl Peroxide; Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050769.pdf Draft Topical Gel 050769 11/01/2019
Benzphetamine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzphetamine_HCl_tab_12427_RC5-06.pdf Final Oral Tablet 012427 05/01/2008
Benztropine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009193.pdf Draft Oral Tablet 009193 09/01/2019
Benzyl Alcohol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022129.pdf Draft Topical Lotion 022129 10/21/2022
Berotralstat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214094.pdf Draft Oral Capsule 214094 08/02/2022
Besifloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022308.pdf Draft Ophthalmic Suspension/Drops 022308 03/01/2020
Betamethasone Acetate; Betamethasone Sodium Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone_Acetate;_Sodium_Phosphate_Inj_14602_RC04-10.pdf Draft Injection Suspension, Injectable 014602 04/01/2010
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_topical Lotion_NDA 01778_RC08-17.pdf Draft Topical Lotion 017781 10/01/2017
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone Dipropionate_topical cream 0.05_RLD 019137_RC09-16.pdf Draft Topical Cream 019137 10/01/2016
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_ topical augmented cream_RLD 19555_RC04-16.pdf Draft Topical Cream, Augmented 019555 04/01/2016
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_topical augmented lotion_RLD 019716_RC01-16.pdf Draft Topical Lotion, Augmented 019716 01/01/2016
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_topical augmented ointment_NDA 018741_RC11-17.pdf Draft Topical Ointment, Augmented 018741 02/01/2018
Betamethasone dipropionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_draft_Topical spray_RLD 208079_RC07-18.pdf Draft Topical Spray 208079 07/01/2018
Betamethasone Dipropionate; Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213422.pdf Draft Topical Cream 213422 10/21/2022
Betamethasone Dipropionate; Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207589.pdf Draft Topical Aerosol, Foam 207589 11/01/2019
Betamethasone Dipropionate; Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021852.pdf Draft Topical Ointment 021852 10/21/2022
Betamethasone Dipropionate; Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022185.pdf Draft Topical Suspension 022185 10/21/2022
Betamethasone dipropionate;Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone Dipropionate; Clotrimazole Lotion NDA 020010 RV Feb 2019.pdf Draft Topical Lotion 020010 02/01/2019
Betamethasone dipropionate;Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone Dipropionate; Clotrimazole Cream NDA 018827 RV Feb 2019.pdf Draft Topical Cream 018827 02/01/2019
Betamethasone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone valerate_topical cream_RLD 018861_RC12-16.pdf Draft Topical Cream 018861 12/01/2016
Betamethasone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone valerate_topical ointment_RLD 18865_RC10-16.pdf Draft Topical Ointment 018865 10/01/2016
Betamethasone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone_valerate_aerofoam_20934_RC12-14.pdf Draft Topical Aerosol, Foam 020934 12/01/2014
Betamethasone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone valerate_topical lotion_RLD 018866_RC01-16.pdf Draft Topical Lotion 018866 01/01/2016
Betaxolol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/BETAXOLOL HYDROCHLORIDE ophthalmic suspensiondrops NDA 019845 PSG Page RV May 2019.pdf Draft Ophthalmic Solution/Drops 019845 05/01/2019
Bethanechol Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bethanechol_Chloride_tab_88440_88441_89096_89095_RC9-08.pdf Draft Oral Tablet 006536 09/01/2008
Betrixaban https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betrixaban_draft_Oral cap_RLD 208383_RC07-18.pdf Draft Oral Capsule 208383 07/01/2018
Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf Draft Oral Capsule 021055 08/20/2021
Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021056.pdf Draft Topical Gel 021056 10/21/2022
Bicalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bicalutamide_tab_20498_RC5-05.pdf Final Oral Tablet 020498 05/01/2008
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bictegravir Sodium, Emtricitabin, Tenofovir Alafenamide Fumarate Oral Tablet NDA 210251 page RC May 2019.pdf Draft Oral Tablet 210251 05/01/2019
Bimatoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bimatoprost_ophthalmic solution drops_NDA 021275_RC11-17.pdf Draft Ophthalmic Solution/Drops 021275 02/01/2018
Bimatoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bimatoprost_ophthalmic solution drops_NDA 022184_RC11-17.pdf Draft Ophthalmic Solution/Drops 022184 02/01/2018
Bimatoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bimatoprost_ophthalmic solution drops_NDA 022369_RC11-17.pdf Draft Topical Solution/Drops 022369 02/01/2018
Binimetinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210498.pdf Draft Oral Tablet 210498 03/01/2020
Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bisacodyl; PEG3350_ANDA 202217_RC03-17.pdf Draft Oral For Solution, Tablet, Delayed Release 021551 05/01/2017
Bismuth Subcitrate Potassium; Metronidazole;Tetracycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/BismuthSubcitratePotassiumMetronidazoleTetracyclineHClcap50786RC908.pdf Draft Oral Capsule 050786 09/01/2008
Bisoprolol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bisoprolol_Fumarate_tab_19982_RC7-05..pdf Final Oral Tablet 019982 05/01/2008
Bisoprolol Fumarate; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bisoprolol_Fumarate_HCTZ_tab_20186_RC7-05.pdf Final Oral Tablet 020186 05/01/2008
Boceprevir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Boceprevir_Cap_202258_RC06-12.pdf Draft Oral Capsule 202258 06/01/2012
Bortezomib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021602.pdf Draft Intravenous, Subcutaneous Injectable 021602 08/01/2020
Bosentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bosentan_tabs_21290_RC09-10.pdf Draft Oral Tablet 021290 03/01/2012
Bosentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bosentan Tablets for oral suspension NDA 209279 RC Feb 2019.pdf Draft Oral Tablet, For Suspension 209279 02/01/2019
Bosutinib Monohydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203341.pdf Draft Oral Tablet 203341 09/01/2019
Bremelanotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210557.pdf Draft Subcutaneous Solution 210557 03/01/2021
Brexanolone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211371.pdf Draft Intravenous Solution 211371 06/01/2020
Brexpiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brexpiprizole_oral tablet_NDA 205422_RC05-17.pdf Draft Oral Tablet 205422 07/01/2017
Brigatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brigatinib_draft_Oral tab_RLD 208772_RC09-18.pdf Draft Oral Tablet 208772 09/01/2018
Brilliant Blue G https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209569.pdf Draft Ophthalmic Solution 209569 12/17/2021
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate ophthalmic solution 0.025 NDA 208144 PSG Page RC May 2019.pdf Draft Ophthalmic Solution/Drops 208144 05/01/2019
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate_ophthalmic solution_NDA 021770_RV08-17.pdf Draft Ophthalmic Solution/Drops 0.1% 021770 10/01/2017
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate_ophthalmic solution_NDA 020613_RV08-17.pdf Draft Ophthalmic Solution/Drops 0.2% 020613 10/01/2017
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate_topical gel_204708_RC09-15.pdf Draft Topical Gel 204708 09/01/2015
Brimonidine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine Tartrate_Ophthalmic Solution_NDA 021262_RV07-17.pdf Draft Ophthalmic Solution/Drops 0.15% 021262 07/01/2017
Brimonidine Tartrate; Brinzolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/BRIMONIDINE TARTRATE BRINZOLAMIDE ophthalmic suspension drops NDA 204251 PSG Page RV May 2019.pdf Draft Ophthalmic Suspension/Drops 204251 05/01/2019
Brimonidine Tartrate;Timolol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate Timolol MaleateNDA 021398 RC 09-2018.pdf Draft Ophthalmic Solution/Drops 021398 09/01/2018
Brinzolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/BRINZOLAMIDE ophthalmic suspension drops NDA 020816 PSG Page RV May 2019.pdf Draft Ophthalmic Suspension/Drops 1% 020816 05/01/2019
Brivaracetam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brivaracetam_oral tablet_NDA 205836_RC05-17.pdf Draft Oral Tablet 205836 07/01/2017
Bromfenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromfenac sodium_ophthalmic solution_NDA 021664_RV08-17.pdf Draft Ophthalmic Solution/Drops 021664 10/01/2017
Bromocriptine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine_ Mesylate_cap_17962_RC11-09.pdf Draft Oral Capsule 017962 11/01/2009
Bromocriptine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine_ Mesylate_tab_17962_RC11-09.pdf Draft Oral Tablet 017962 11/01/2009
Bromocriptine mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine Mesylate Tablets NDA20866 RC Feb 2019.pdf Draft Oral Tablet 020866 02/01/2019
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020746.pdf Draft Nasal Spray, Metered 020746 08/01/2020
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021324.pdf Draft Oral Capsule, Delayed Release 021324 08/20/2021
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_inhalation powder_RLD 21949_RC12-16.pdf Draft Inhalation Powder 021949 12/01/2016
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_Inhalation_Sus_20929_RC_09-12.pdf Draft Inhalation Suspension 020929 09/01/2012
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_ERTab_203634_RC12-14.pdf Draft Oral Tablet, Extended Release 203634 12/01/2014
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205613.pdf Draft Rectal Aerosol, Foam 205613 11/18/2020
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215935.pdf Draft Oral Capsule, Delayed Release 215935 11/17/2022
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211929.pdf Draft Oral Capsule, Extended Release 211929 03/01/2020
Budesonide; Formoterol Fumarate Dihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide and Formoterol fumarate dihydrate_MDI_021929_RC06-15.pdf Draft Inhalation Aerosol, Metered 021929 06/01/2015
Bumetanide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bumetanide_tab_74700_RV11-13.pdf Draft Oral Tablet 018225 11/01/2013
Bupivacaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupivacaine_ liposomal injectable injection_NDA 022496_RC11-17.pdf Draft Injection Injectable, Liposomal 022496 02/01/2018
Bupivacaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204803.pdf Draft Infiltration Solution, Extended Release 204803 05/19/2022
Buprenorphine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209819.pdf Draft Subcutaneous Solution, Extended Release 209819 06/01/2020
Buprenorphine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021306.pdf Draft Transdermal Film, Extended Release 021306 06/01/2020
Buprenorphine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine_hydrochloride_SLtab_78633_RV02-14.pdf Draft Sublingual Tablet 020732 02/01/2014
Buprenorphine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine hydrochloride_buccal film_NDA 207932_RC11-17.pdf Draft Buccal Film 207932 02/01/2018
Buprenorphine Hydrochloride; Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine HCL_Naloxone HCL_Buccal Film_205637_RC03-15.pdf Draft Buccal Film 205637 03/01/2015
Buprenorphine Hydrochloride; Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine HCL; Naloxone HCL_sublingual buccal film_RLD 022410_RV12-16.pdf Draft Buccal, Sublingual Film 022410 12/01/2016
Buprenorphine Hydrochloride; Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine_HCl;_Naloxone_HCl_subtab_20733_RC5-10.pdf Draft Sublingual Tablet 020733 05/01/2010
Buprenorphine Hydrochloride; Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine Hcl; Naloxone Hcl_sublingual tablet_RLD 204242_RV12-16.pdf Draft Sublingual Tablet 204242 12/01/2016
Bupropion Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HBr_ERtab_22108_RV03-13.pdf Draft Oral Tablet, Extended Release 022108 03/01/2013
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_ERtab_22497_RC03-13.pdf Draft Oral Tablet, Extended Release 022497 03/01/2013
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_tab_18644_RV03-13.pdf Draft Oral Tablet 018644 03/01/2013
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_ERtab_21515_RV03-13.pdf Draft Oral Tablet, Extended Release 021515 03/01/2013
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_ERtab_20358_20711_RV03-13.pdf Draft Oral Tablet, Extended Release 020358 020711 03/01/2013
Bupropion Hydrochloride; Naltrexone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200063.pdf Draft Oral Tablet, Extended Release 200063 11/18/2020
Buspirone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buspirone_tab_18731_RC12-09.pdf Draft Oral Tablet 018731 12/01/2009
Busulfan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Busulfan_tab_09386_RC7-08.pdf Draft Oral Tablet 009386 07/01/2009
Butenafine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020524.pdf Draft Topical Cream 020524 10/21/2022
Butenafine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021307.pdf Draft Topical Cream 021307 10/21/2022
Butoconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Butoconazole Nitrate Vaginal Cream ANDA 200923 RV Feb 2019.pdf Draft Vaginal Cream 200923 02/01/2019
Butoconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Butoconazole Nitrate Vaginal Cream NDA 020421 RV Feb 2019.pdf Draft Vaginal Cream 020421 02/01/2019
Cabotegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212887.pdf Draft Oral Tablet 212887 08/02/2022
Cabozantinib S Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cabozantinib S-malate_oral capsules_NDA 203756_RC11-17.pdf Draft Oral Capsule 203756 02/01/2018
Cabozantinib S malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cabozantinib S-Malate_oral tablet_NDA 208692_RC11-17.pdf Draft Oral Tablet 208692 02/01/2018
Calcifediol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208010.pdf Draft Oral Capsule, Extended Release 208010 03/24/2021
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022563.pdf Draft Topical Aerosol, Foam 022563 11/18/2020
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020554.pdf Draft Topical Cream 020554 10/21/2022
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020273.pdf Draft Topical Ointment 020273 10/21/2022
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcipotriene_sol_20611_RC08-10.pdf Draft Topical Solution 020611 08/01/2010
Calcitonin Salmon https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017769.pdf Draft Injection Injectable 017808 11/17/2022
Calcitonin Salmon https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020313.pdf Draft Nasal Spray, Metered 020313 03/01/2020
Calcitriol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcitriol_cap _18044_RC7-08.pdf Draft Oral Capsule 018044 09/01/2010
Calcium Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcium acetate_oral tablet_ANDA 078502_RV03-17.pdf Draft Oral Tablet 019976 05/01/2017
Calcium Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/calcium acetate_oral capsule_RLD 021160_RV03-17.pdf Draft Oral Capsule 021160 05/01/2017
Calcium Carbonate; Famotidine; Magnesium Hydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020958.pdf Draft Oral Tablet, Chewable 020958 11/17/2022
Calcium Carbonate;Risedronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Risedronate_Sodium_Calcium_Carbonate_tab_21823_RC10-06.pdf Final Oral Tablet, Tablet 021823 05/01/2008
Canagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Canagliflozin_tab_204042_RC07-14.pdf Draft Oral Tablet 204042 07/01/2014
Canagliflozin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Canagliflozin; Metformin HCl_oral ER tablet_NDA 205879_RC08-17.pdf Draft Oral Tablet, Extended Release 205879 10/01/2017
Canagliflozin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Canagliflozin and Metformin HCl_oral tablet_204353_RC06-15.pdf Draft Oral Tablet 204353 06/01/2015
Candesartan Cilexetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Candesartan_Cilexetil_tab_20838_RC8-04.pdf Final Oral Tablet 020838 05/01/2008
Candesartan Cilexetil; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Candesartan_Cilexetil_HCTZ_tab_21093 _RC8-04.pdf Draft Oral Tablet 021093 09/01/2008
Cannabidiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210365.pdf Draft Oral Solution 210365 03/01/2021
Capecitabine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Capecitabine_Tabs_20896_RC09-12.pdf Draft Oral Tablet 020896 09/01/2012
Capmatinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213591.pdf Draft Oral Tablet 213591 02/17/2022
Capsaicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022395.pdf Draft Topical Patch 022395 11/01/2019
Captopril https://www.accessdata.fda.gov/drugsatfda_docs/psg/Captopril_oral tablet_RLD 074434_RC09-16.pdf Draft Oral Tablet 018343 10/01/2016
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_oral tablet_016608_RV09-15.pdf Draft Oral Tablet 016608 09/01/2015
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_ER tab_020234_RV03-15.pdf Draft Oral Tablet, Extended Release 020234 03/01/2015
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_Oral ER cap_20712_RV03-15.pdf Draft Oral Capsule, Extended Release 020712 021710 03/01/2015
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_oral suspension_18927_RV03-15.pdf Draft Oral Suspension 018927 03/01/2015
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018281.pdf Draft Oral Tablet, Chewable 018281 08/02/2022
Carbidopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa_Tabs_017830_RC07-14.pdf Draft Oral Tablet 017830 07/01/2014
Carbidopa; Entacapone; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa_entacapone_levodopa_tab_21485_RV06-13.pdf Draft Oral Tablet 021485 06/01/2013
Carbidopa; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa; Levedopa_enteral suspension_RLD 203952_RC03-17.pdf Draft Enteral Suspension 203952 05/01/2017
Carbidopa; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa; Levodopa_oral tablet_RLD 17555_RC09-16.pdf Draft Oral Tablet 017555 10/01/2016
Carbidopa; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa; Levodopa_oral ER capsule_203312_RC09-15.pdf Draft Oral Capsule, Extended Release 203312 09/01/2015
Carbidopa; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa_Levodopa_ERtab_19856_RC09-12.pdf Draft Oral Tablet, Extended Release 019856 09/01/2012
Carbidopa; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_076699.pdf Draft Oral Tablet, Orally Disintegrating 078690 11/01/2021
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008915.pdf Draft Oral Tablet 008915 08/20/2021
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbinoxamine_maleate_oralsusp_22556_RC07-14.pdf Draft Oral Suspension, Extended Release 022556 07/01/2014
Carglumic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022562.pdf Draft Oral Tablet 022562 06/01/2020
Cariprazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204370.pdf Draft Oral Capsule 204370 11/01/2019
Carisoprodol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carisoprodol_tabs_11792_RC3-10.pdf Draft Oral Tablet 011792 03/01/2010
Carvedilol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carvedilol_tab_20297_RC10-05.pdf Final Oral Tablet 020297 05/01/2008
Carvedilol Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carvedilol_Phosphate_ERcap_22012_RC2-10.pdf Draft Oral Capsule, Extended Release 022012 02/01/2010
Caspofungin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021227.pdf Draft Intravenous Powder 021227 08/02/2022
Cedazuridine; Decitabine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212576.pdf Draft Oral Tablet 212576 05/19/2022
Cefaclor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050673.pdf Draft Oral Tablet, Extended Release 050673 11/01/2019
Cefaclor https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefaclor_cap_65350_RC2-11.pdf Draft Oral Capsule 050521 02/01/2011
Cefadroxil; Cefadroxil Hemihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefadroxil;_Cefadroxil_Hemihydrate_65282_RC09-10.pdf Draft Oral Capsule 050512 09/01/2010
Cefdinir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefdinir_cap_50739_RC1-08.pdf Draft Oral Capsule 050739 01/01/2008
Cefdinir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefdinir_oral powder for suspension_ NDA 050749_RC05-17.pdf Draft Oral Powder For Suspension 050749 07/01/2017
Cefditoren Pivoxil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefditoren_Pivoxil_tab_RLD 21222_RV3-10 minor edit after post.pdf Final Oral Tablet 021222 11/01/2015
Cefiderocol Sulfate Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209445.pdf Draft Intravenous Powder 209445 08/20/2021
Cefixime https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_chewtab_65380 RC07-14.pdf Draft Oral Tablet, Chewable 065380 07/01/2014
Cefixime https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_cap_203195_RC04-13.pdf Draft Oral Capsule 203195 04/01/2013
Cefixime https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_tab_65130_RC2-11.pdf Draft Oral Tablet 050621 02/01/2011
Cefixime https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_susp_202091_RV11-13.pdf Draft Oral Suspension 202091 11/01/2013
Cefpodoxime Proxetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefpodoxime_Proxetil_Susp_65409_RC06-12.pdf Draft Oral Suspension 050675 06/01/2012
Cefpodoxime Proxetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefpodoxime_Proxetil_Tab_65462_RC06-12.pdf Draft Oral Tablet 050674 06/01/2012
Cefprozil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefprozil_Susp_65261_RC06-12.pdf Draft Oral Suspension 050665 06/01/2012
Cefprozil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefprozil_Tab_65276_RC06-12.pdf Draft Oral Tablet 050664 06/01/2012
Cefuroxime Axetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefuroxime_Axetil_tab_50605_RC08-10.pdf Draft Oral Tablet 050605 08/01/2010
Cefuroxime Axetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefuroxime_Axetil_susp_50672_RC02-10.pdf Draft Oral Suspension 050672 02/01/2010
Celecoxib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Celecoxib_cap_20998_RV11-13.pdf Draft Oral Capsule 020998 11/01/2013
Cenobamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212839.pdf Draft Oral Tablet 212839 11/08/2021
Cephalexin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cephalexin_oral suspension_RLD 062703_RC12-16.pdf Draft Oral Suspension 050406 12/01/2016
Cephalexin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cephalexin_cap_50405_RC12-08.pdf Final Oral Capsule 050405 10/01/2011
Ceritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ceritinib Oral Capsule NDA 205755 RV Feb 2019.pdf Draft Oral Capsule 205755 02/01/2019
Ceritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211225.pdf Draft Oral Tablet 211225 11/18/2020
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022578.pdf Draft Oral Tablet, Orally Disintegrating 022578 11/08/2021
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021621.pdf Draft Oral Tablet, Chewable 021621 08/02/2022
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cetirizine hydrochloride_oral tablet_RLD 019835_RC12-16.pdf Draft Oral Tablet 019835 12/01/2016
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cetirizine HCl_oral capsule_RLD 022429_Final 08-17.pdf Final Oral Capsule 022429 08/01/2017
Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cetirizine_HCl;_Pseudoephedrine_HCl_ERtab_21150_RC2-08.pdf Draft Oral Tablet, Extended Release 021150 02/01/2008
Cevimeline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cevimeline_HCl_cap_20989_RC9-05.pdf Final Oral Capsule 020989 05/01/2008
Chenodiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018513.pdf Draft Oral Tablet 018513 09/01/2019
Chlorambucil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorambucil_tabs_10669_RC07-10.pdf Draft Oral Tablet 010669 07/01/2010
Chlordiazepoxide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012249.pdf Draft Oral Capsule 012249 085475 085461 085472 09/01/2019
Chlordiazepoxide Hydrochloride; Clidinium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlordiazepoxide clindinium_oral capsule_RLD 012750_RC03-17.pdf Draft Oral Capsule 012750 05/01/2017
Chlorhexidine Gluconate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020774.pdf Draft Dental Tablet 020774 05/19/2022
Chloroquine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_006002.pdf Final Oral Tablet 006002 04/01/2020
Chlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorothiazide Oral Suspension NDA 011870 PSG Page RC Feb 2019.pdf Draft Oral Suspension 011870 02/01/2019
Chlorpheniramine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_007638.pdf Draft Oral Tablet, Extended Release 007638 09/01/2019
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ChlorpheniramineMaleateIbuprofenPhenylephrine HCltablet022113RC03_15.pdf Draft Oral Tablet 022113 03/01/2015
Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpheniramine maleate; Ibuprofen; Pseudoephendrine HCl Tablet 2mg; 200mg; 30mg NDA 021441 PSG Page RC May 2019.pdf Draft Oral Tablet 021441 05/01/2019
Chlorpheniramine Polistirex; Codeine Polistirex https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpheniramine_polistirex_Codpoli_207768_RC04-16.pdf Draft Oral Suspension, Extended Release 207768 04/01/2016
Chlorpheniramine Polistirex; Hydrocodone Polistirex https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpheniramine_Polistirex;_Hydrocodone_Polistirex_susp_19111_RC2-10.pdf Draft Oral Suspension, Extended Release 019111 02/01/2010
Chlorpheniramine Polistirex; Hydrocodone Polistirex https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpheniramine_Polistirex;_ Hydrocodone_Plistirex_ERcap_77273_RC12-08.pdf Draft Oral Capsule, Extended Release 077273 12/01/2008
Chlorpromazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpromazine Hydrochloride Oral Tablet ANDA 84114 RV 09-2018.pdf Draft Oral Tablet 084112 084114 09/01/2018
Chlorpromazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009149.pdf Draft Oral Concentrate 009149 09/01/2019
Chlorthalidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012283.pdf Draft Oral Tablet 50 mg; 25 mg 012283 09/01/2019
Chlorthalidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019574.pdf Draft Oral Tablet 25 mg; 15 mg 019574 09/01/2019
Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011300.pdf Draft Oral Tablet 011300 11/01/2019
Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011529-Tab-500MG.pdf Draft Oral Tablet 500 mg 011529 11/01/2019
Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011529-Tab-750MG.pdf Draft Oral Tablet 750 mg 011529 11/01/2019
Cholestyramine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cholestyramine_oral powder_74557 and 74558_RV06-15.pdf Draft Oral Powder 016640 019669 06/01/2015
Cholic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cholic acidz_oral capsule_RLD 205750_RC03-16.pdf Draft Oral Capsule 205750 10/01/2016
Choline Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Copy of Choline_Fenofibrate_DRtabs_22224_RC12-10.pdf Draft Oral Capsule, Delayed Release 022224 12/01/2010
Ciclesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclesonide Nasal Aerosol 202129 RC09-12.pdf Draft Nasal Aerosol, Metered 202129 09/01/2012
Ciclesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022004.pdf Draft Nasal Spray, Metered 022004 11/08/2021
Ciclesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021658.pdf Draft Inhalation Aerosol, Metered 021658 03/24/2021
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox_soln_21022_ RC2-10.pdf Draft Topical Solution 021022 02/01/2011
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Suspension NDA 019824 RV Feb 2019.pdf Draft Topical Suspension 019824 02/01/2019
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Cream NDA 018748 RV Feb 2019.pdf Draft Topical Cream 018748 02/01/2019
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Gel NDA 020519 RV Feb 2019.pdf Draft Topical Gel 020519 02/01/2019
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox_shmp_21159_RC2-10.pdf Draft Topical Shampoo 021159 02/01/2010
Cilastatin Sodium; Imipenem; Relebactam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212819.pdf Draft Intravenous Powder 212819 07/15/2021
Cilostazol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cilostazol_tab_20863_RC10-05.pdf Final Oral Tablet 020863 05/01/2008
Cinacalcet Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cinacalcet_HCl_tab_21688_RC11-05.pdf Final Oral Tablet 021688 05/01/2008
Ciprofloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_susp_20780_RC5-09.pdf Final Oral Suspension 020780 10/01/2011
Ciprofloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_draft_Otic susp injec_RLD 207986_RC07-18.pdf Draft Otic Suspension, Injectable 207986 07/01/2018
Ciprofloxacin hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_draft_Ophthalmic ointment_RLD_020369_RC09-18.pdf Draft Ophthalmic Ointment 020369 09/01/2018
Ciprofloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin hydrochloride_ophthalmic solution_NDA 019992_RV08-17.pdf Draft Ophthalmic Solution/Drops 019992 10/01/2017
Ciprofloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_tabs_19537_RC09-10.pdf Draft Oral Tablet 019537 09/01/2010
Ciprofloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_ERtab_21744_RC11-07.pdf Draft Oral Tablet, Extended Release 021744 11/01/2007
Ciprofloxacin Hydrochloride; Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin HCL_Hydrocortisone_Otic susp_RLD 020805_RV01-16.pdf Draft Otic Suspension/Drops 020805 01/01/2016
Ciprofloxacin; Ciprofloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin; Ciprofloxacin Hydrochloride_ERtab_21473_RC1-08.pdf Draft Oral Tablet, Extended Release 021473 01/01/2008
Ciprofloxacin; Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_Dexamethasone_Otic suspension_RLD 021537_RV04-16.pdf Draft Otic Suspension/Drops 021537 04/01/2016
Citalopram Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Citalopram hydrobromide_Oral Capsule_RLD 77668_Final 08-17.pdf Final Oral Capsule 077668 08/01/2017
Citalopram Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Citalopram hydrobromide_Oral Tablet_RLD 20822_Final 08-17.pdf Final Oral Tablet 020822 08/01/2017
Cladribine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022561.pdf Draft Oral Tablet 022561 02/17/2022
Clarithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clarithromycin_Oral Tablet_RLD 50662_Final 08-17.pdf Final Oral Tablet 050662 08/01/2017
Clarithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clarithromycin_ERtab_50775_RC1-08.pdf Draft Oral Tablet, Extended Release 050775 01/01/2008
Clarithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clarithromycin_susp_50698_RC5-05.pdf Final Oral Suspension 050698 05/01/2008
Clascoterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213433.pdf Draft Topical Cream 213433 11/08/2021
Clemastine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017661.pdf Draft Oral Tablet 2.68 mg 017661 09/01/2019
Clemastine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020925.pdf Draft Oral Tablet 1.34 mg 020925 09/01/2019
Clevidipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022156.pdf Draft Intravenous Emulsion 022156 03/01/2020
Clindamycin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin HCl_Oral Capsule_RLD 50162_Final 08-17.pdf Final Oral Capsule 050162 08/01/2017
Clindamycin Phosphae https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050782.pdf Draft Topical Gel 050782 10/21/2022
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050537-Sol.pdf Draft Topical Solution 050537 06/01/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050537-Swa.pdf Draft Topical Swab 050537 06/01/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050801.pdf Draft Topical Aerosol, Foam 050801 06/01/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215650.pdf Draft Vaginal Gel 215650 11/17/2022
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin_Phosphate_crm_50680_RC03-12.pdf Draft Vaginal Cream 050680 03/01/2012
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin_Phosphate_crm_50793_RC03-12.pdf Draft Vaginal Cream 050793 03/01/2012
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin_Phosphate_supp_50767_RC03-12.pdf Draft Vaginal Suppository 050767 03/01/2012
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050615.pdf Draft Topical Gel 050615 10/21/2022
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050600.pdf Draft Topical Lotion 050600 10/21/2022
Clindamycin Phosphate; Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050802.pdf Draft Topical Gel 050802 10/21/2022
Clindamycin Phosphate; Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050803.pdf Draft Topical Gel 050803 10/21/2022
Clobazam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210833.pdf Draft Oral Film 210833 11/18/2020
Clobazam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobazam_susp_203993_RC02-14.pdf Draft Oral Suspension 203993 04/01/2014
Clobazam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobazam_tab_202067_RV11-13.pdf Draft Oral Tablet 202067 11/01/2013
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol Propionate_Emollient Cream 0.05_RLD 75430_RC09-16.pdf Draft Topical Cream 020340 10/01/2016
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol Propionate_topical gel 0.05_RLD 75368_RC09-16.pdf Draft Topical Gel 020337 10/01/2016
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol propionate_topical cream_RLD 74220_RC04-16.pdf Draft Topical Cream 019322 04/01/2016
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol propionate_topical lotion_RLD 21535_RC04-16.pdf Draft Topical Lotion 021535 04/01/2016
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_fmaerosol_21142_RC2-11.pdf Draft Topical Aerosol, Foam 021142 02/01/2011
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_shmp_21644_RC2-11.pdf Draft Topical Shampoo 021644 02/01/2011
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_spray_21835_RC2-11.pdf Draft Topical Spray 021835 02/01/2011
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_sol_19966_RC08-10.pdf Draft Topical Solution 019966 08/01/2010
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol propionate_topical ointment_RLD 019323_RC01-16.pdf Draft Topical Ointment 019323 01/01/2016
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022013.pdf Draft Topical Aerosol, Foam 022013 11/18/2020
Clocortolone Pivalate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clocortolone pivalate_topical cream_ NDA 017765_RC05-17.pdf Draft Topical Cream 017765 07/01/2017
Clomiphene Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clomiphene citrate_Oral tablet_RLD 16131_Final 08-17.pdf Final Oral Tablet 016131 08/01/2017
Clomipramine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clomipramine hydrochloride_oral capsule_019906_RC09-15.pdf Draft Oral Capsule 019906 09/01/2015
Clonazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonazepam_orally disintegrating tablet_ANDA 077171_RC03-17.pdf Draft Oral Tablet, Orally Disintegrating 020813 05/01/2017
Clonazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonazepam_Oral Tablet_RLD 17533_Final 08-17.pdf Final Oral Tablet 017533 08/01/2017
Clonidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonidine_ERtab_22500_RC08-10.pdf Draft Oral Tablet, Extended Release 022500 08/01/2010
Clonidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018891.pdf Draft Transdermal Film, Extended Release 018891 11/01/2019
Clonidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonidine hydrochloride_oral tablet_022331_RC09-15.pdf Draft Oral Tablet, Extended Release 022331 09/01/2015
Clonidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017407.pdf Draft Oral Tablet 017407 11/01/2019
Clopidogrel Bisulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clopidogrel_Bisulfate_tab_20839_RC10-05.pdf Draft Oral Tablet 020839 08/01/2008
Clorazepate Dipotassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clorazepate_Dipotassium_tab_17105_RC12-12.pdf Draft Oral Tablet 017105 12/01/2012
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Topical Solution NDA 018181 RV Feb 2019.pdf Draft Topical Solution 018181 02/01/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Topical Cream ANDA 072640 RV Feb 2019.pdf Draft Topical Cream 072640 02/01/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Cream NDA 018052 RV Feb 2019.pdf Draft Vaginal Cream 018052 02/01/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Cream NDA 020574 RV Feb 2019.pdf Draft Vaginal Cream 020574 02/01/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Tablet NDA 017717 RV Feb 2019.pdf Draft Vaginal Tablet 017717 02/01/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Tablet NDA 020525 RV Feb 2019.pdf Draft Vaginal Tablet 020525 02/01/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole_loz_18713_RC9-08.pdf Draft Oral Troche/Lozenge 018713 09/01/2008
Clozapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203479.pdf Draft Oral Suspension 203479 02/17/2022
Clozapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019758.pdf Draft Oral Tablet 019758 02/17/2022
Clozapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021590.pdf Draft Oral Tablet, Orally Disintegrating 021590 02/17/2022
Cobicistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat_oral tablet_203094_RC09-15.pdf Draft Oral Tablet 203094 09/01/2015
Cobicistat; Darunavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat; Darunavir ethanolate_oral tablet_RLD 205395_RV12-16.pdf Draft Oral Tablet 205395 12/01/2016
Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210455.pdf Draft Oral Tablet 210455 08/02/2022
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat; ElviteNDA 207561_RV08-17.pdf Draft Oral Tablet 207561 10/01/2017
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat_Elvitegravir..._203100_RC12-14.pdf Draft Oral Tablet 203100 12/01/2014
Cobimetinib Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobimetinib Fumarate _oral tablet_RLD 206192_RC06-16.pdf Draft Oral Tablet 206192 06/01/2016
Cocaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209575.pdf Draft Nasal Solution 209575 05/19/2022
Cocaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209963.pdf Draft Nasal Solution 209963 12/01/2019
Colchicine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Colchicine_oral capsule_RLD 204820_RC12-16.pdf Draft Oral Capsule 204820 12/01/2016
Colchicine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Colchicine_tab_22352_RC09-10.pdf Draft Oral Tablet 022352 09/01/2010
Colesevelam Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021176.pdf Draft Oral Tablet 021176 11/08/2021
Colesevelam Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022362.pdf Draft Oral For Suspension 022362 11/01/2021
Colesevelam Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210895.pdf Draft Oral Bar, Chewable 210895 11/08/2021
Colestipol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Colestipol_Hydrochloride_tab_20222_RC07-14.pdf Draft Oral Tablet 020222 07/01/2014
Copper https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018680.pdf Draft Intrauterine Intrauterine Device 018680 11/01/2019
Copper Dotatate Cu-64 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213227.pdf Draft Intravenous Solution 213227 08/20/2021
Crisaborole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207695.pdf Draft Topical Gel 207695 10/21/2022
Crizotinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Crizotinib_Caps_202570_RC07-14.pdf Draft Oral Capsule 202570 07/01/2014
Crofelemer https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202292.pdf Draft Oral Tablet, Delayed Release 202292 11/18/2020
Crotamiton https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_006927.pdf Draft Topical Cream 006927 10/21/2022
Crotamiton https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009112.pdf Draft Topical Lotion 009112 10/21/2022
Cyanocobalamin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyanocobalamin_nasal metered spray_NDA 021642_RC05-17.pdf Draft Nasal Spray 021642 07/01/2017
Cyclobenzaprine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclobenzaprine HCl_oral tablet _RLD 17821_final 08-17.pdf Final Oral Tablet 017821 08/01/2017
Cyclobenzaprine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclobenzaprine HCL_oral ER capsule_RLD 21777_RV12-16.pdf Draft Oral Capsule, Extended Release 021777 11/01/2016
Cyclophosphamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclophosphamide_oral tablet_040032_RV09-15.pdf Draft Oral Tablet 040032 09/01/2015
Cyclophosphamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclophosphamide_oral capsule_203856_RC06-15.pdf Draft Oral Capsule 203856 06/01/2015
Cycloserine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cycloserine_oral capsule_RLD 060593_Final 08-17.pdf Final Oral Capsule 060593 08/01/2017
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine_Oral capsule_RLD 050625_RV04-16.pdf Draft Oral Capsule 050625 04/01/2016
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine_Oral capsule_RLD 050715_RV04-16.pdf Draft Oral Capsule 050715 04/01/2016
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine_ophthalmic emulsion_RLD 050790_RV09-16.pdf Draft Ophthalmic Emulsion 050790 10/01/2016
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214965.pdf Draft Ophthalmic Emulsion 214965 08/02/2022
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine ophthalmic solution 0.09 NDA 210913 PSG Page RC May 2019.pdf Draft Ophthalmic Solution/Drops 210913 05/01/2019
Cyproheptadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyproheptadine hydrochloride_Oral tablet_087056_RC06-15.pdf Draft Oral Tablet 012649 06/01/2015
Cysteamine Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cysteamine bitartrate_oral DR capsule_NDA 203389_RV11-17.pdf Draft Oral Capsule, Delayed Release 203389 02/01/2018
Cysteamine Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213491.pdf Draft Oral Granule, Delayed Release 213491 03/24/2021
Cytarabine; Daunorubicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209401.pdf Draft Intravenous Powder 209401 08/02/2022
Dabigatran Etexilate Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dabigatran etexilate mesylate_oral capsule_NDA 022512_RV05-17.pdf Draft Oral Capsule 022512 07/01/2017
Dabrafenib Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dabrafenib mesylate_oral capsule_202806_RC06-15.pdf Draft Oral Capsule 202806 06/01/2015
Daclatasvir Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Daclatasvir dihydrochloride_oral tablet_NDA 206843_RV11-17.pdf Draft Oral Tablet 206843 02/01/2018
Dacomitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211288.pdf Draft Oral Tablet 211288 03/01/2020
Dalfampridine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dalfampridine_ERtab_22250_RC03-12.pdf Draft Oral Tablet, Extended Release 022250 03/01/2012
Dalteparin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dalteparin_Inj_20287_RC09-12.pdf Draft Subcutaneous Injectable 020287 09/01/2012
Danazol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Danazol_cap_74582_RC10-05.pdf Final Oral Capsule 074582 05/01/2008
Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205579.pdf Draft Intravenous For Suspension 205579 08/02/2022
Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017443.pdf Draft Oral Capsule 017443 09/01/2019
Dapagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202293.pdf Draft Oral Tablet 202293 06/01/2020
Dapagliflozin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205649.pdf Draft Oral Tablet, Extended Release 205649 03/01/2020
Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210874.pdf Draft Oral Tablet, Extended Release 210874 03/01/2020
Dapagliflozin; Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209091.pdf Draft Oral Tablet 209091 06/01/2020
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207154.pdf Draft Topical Gel 207154 10/21/2022
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dapsone_oral tablet_ANDA 086842_Final 08-17.pdf Final Oral Tablet 086841 086842 08/01/2017
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021794.pdf Draft Topical Gel 021794 10/21/2022
Daptomycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/DAPTOMYCIN IV infusion powder NDA 209949 & NDA 208385 Page Feb 2019.pdf Draft IV Infusion Powder 209949 208385 02/01/2019
Darifenacin Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Darifenacin_HBr_ERtab_21513_RC8-05.pdf Final Oral Tablet, Extended Release 021513 05/01/2008
Darolutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212099.pdf Draft Oral Tablet 212099 08/01/2020
Darunavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Darunavir_Ethanolate_tab_21976_RV04-13.pdf Draft Oral Tablet 021976 04/01/2013
Darunavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Darunavir_ethanolate_susp_202895_RC12-14.pdf Draft Oral Suspension 202895 12/01/2014
Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/DasabuvirNa; Ombitasvir; Paritaprevir; Ritonavir_RC05-17.pdf Draft Oral Tablet, Extended Release 208624 07/01/2017
Dasabuvir Sodium;Ombitasvir;Paritaprevir;Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Obitasvir_paritaprevir_ritonavir_dasabuvir_oral tablet_206619_RC09-15.pdf Draft Oral Tablet, Tablet 206619 09/01/2015
Dasatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021986.pdf Draft Oral Tablet 021986 05/01/2021
Dasiglucagon Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214231.pdf Draft Subcutaneous Solution 214231 08/02/2022
Daunorubicin Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050704.pdf Draft Injection Injectable, Liposomal 050704 11/17/2022
Deferasirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_oral tablet_RLD 206910_RC04-16.pdf Draft Oral Tablet 206910 04/01/2016
Deferasirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_susp_21882_RC5-06.pdf Final Oral Tablet, For Suspension 021882 05/01/2008
Deferasirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_draft_Oral gran_RLD 207968_RC07-18.pdf Draft Oral Granule 207968 07/01/2018
Deferiprone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021825.pdf Draft Oral Tablet 021825 11/17/2022
Deferiprone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212269.pdf Draft Oral Tablet 212269 11/17/2022
Deflazacort https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deflazacort_oral suspension_NDA 208685_RC08-17.pdf Draft Oral Suspension 208685 10/01/2017
Deflazacort https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deflazacort_oral tablet_NDA 208684_RC08-17.pdf Draft Oral Tablet 208684 10/01/2017
Degarelix Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022201.pdf Draft Subcutaneous Powder 022201 03/24/2021
Delafloxacin meglumine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Delafloxacin meglumine_draft_Oral tab_RLD 208610_RC09-18.pdf Draft Oral Tablet 208610 09/01/2018
Delavirdine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Delavirdine_Mesylate 20705_RC11-07.pdf Draft Oral Tablet 020705 11/01/2007
Demeclocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Demeclocycline_HCl_tab_50261_RC10-08.pdf Draft Oral Tablet 050261 10/01/2008
Desipramine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desipramine HCl_ oral tablet_ RLD 14399_Final 08-17.pdf Final Oral Tablet 014399 08/01/2017
Desloratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desloratadine_tab_21165_RC10-05.pdf Final Oral Tablet 021165 05/01/2008
Desloratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021312.pdf Draft Oral Tablet, Orally Disintegrating 021312 11/08/2021
Desloratadine; Pseudoephedrine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desloratadine_Pseudoephedrine_Oral_Extended_Release_Tablet_NDA_021313_PSG_Page_RC_May_2019.pdf Draft Oral Tablet, Extended Release 021313 05/01/2019
Desmopressin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desmopressin acetate Sublingual Tablets NDA 022517 PSG Page RC May 2019.pdf Draft Sublingual Tablet 022517 05/01/2019
Desmopressin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desmopressin acetate_ oral tablet_ RLD19955_Final 08-17.pdf Final Oral Tablet 019955 08/01/2017
Desogestrel; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desogestrel;_Ethiny_ Estradiol_tab_20301_RC4-09.pdf Draft Oral Tablet 020301 03/01/2010
Desogestrel; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desogestrel;_Ethinyl_Estradiol_(Cyclessa)_21090_RC3-09.pdf Draft Oral Tablet 021090 03/01/2009
Desogestrel; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desogestrel;_EE _(mircette)_tab_20713_RC8-08.pdf Draft Oral Tablet 020713 07/01/2009
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical ointment_RLD 017426_RC09-16.pdf Draft Topical Ointment 017426 10/01/2016
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical cream_RLD 017010_RC01-16.pdf Draft Topical Cream 017010 01/01/2016
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical lotion_RLD 072354_RC01-16.pdf Draft Topical Lotion 072354 01/01/2016
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_draft_Topical gel_RLD 021844_RC09-18.pdf Draft Topical Gel 021844 09/01/2018
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021978.pdf Draft Topical Aerosol, Foam 021978 11/18/2020
Desoximetasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desoximetasone_topical spray 0.25_204141_RC03-15.pdf Draft Topical Spray 204141 03/01/2015
Desoximetasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desoximetasone_cream_073210_073193_RC02-14.pdf Draft Topical Cream 017856 018309 04/01/2014
Desoximetasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desoximetasone_ointment_18594_74286_RC02-14.pdf Draft Topical Ointment 018594 018763 04/01/2014
Desvenlafaxine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204150.pdf Draft Oral Tablet, Extended Release 204150 06/01/2020
Desvenlafaxine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204683.pdf Draft Oral Tablet, Extended Release 204683 06/01/2020
Desvenlafaxine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205583.pdf Draft Oral Tablet, Extended Release 205583 06/01/2020
Desvenlafaxine Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021992.pdf Draft Oral Tablet, Extended Release 021992 06/01/2020
Deutetrabenazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deutetrabenazine_draft_Oral tab_RLD 208082_RC09-18.pdf Draft Oral Tablet 208082 09/01/2018
Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone_tabs_88316_84612_87916_88306_84610_84613_84611_RC06-11.pdf Draft Oral Tablet 011664 06/01/2011
Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone Oral Concentrate Solution ANDA 088252 RC Feb 2019.pdf Draft Oral Concentrate 088252 02/01/2019
Dexamethasone; Neomycin sulfate; Polymyxin B sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone; Neomycin sulfate; Polymyxin B sulfate_draft_Ophthalmic susp drops_RLD 050023_RC07-18.pdf Draft Ophthalmic Suspension/Drops 050023 07/01/2018
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone; Tobramycin_ophthalmic ointment_RLD 050616_RV06-16.pdf Draft Ophthalmic Ointment 050616 06/01/2016
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone Tobramycin_ophthalmic suspension NDA 50818 RV Feb 2019.pdf Draft Ophthalmic Suspension 050818 02/01/2019
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone; Tobramycin_ophthalmic suspension NDA 50592 RV Feb 2019.pdf Draft Ophthalmic Suspension 050592 02/01/2019
Dexbrompheniramine Maleate; Pseudoephedrine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexbrompheniramine maleate Pseudoephedrine sulfate_078648_RC06-15.pdf Draft Oral Tablet, Extended Release 013483 06/01/2015
Dexlansoprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexlansoprazole_orally disintegrating DR tablet_NDA 208056_RV11-17.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 208056 02/01/2018
Dexlansoprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexlansoprazole_oral DR capsule_NDA 022287_RV11-17.pdf Draft Oral Capsule, Delayed Release 022287 02/01/2018
Dexmethylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexmethylphenidate_tab_21278_RC2-08.pdf Draft Oral Tablet 021278 02/01/2008
Dexmethylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexmethylphenidate HCL_Oral ER cap_21802_RV03-15.pdf Draft Oral Capsule, Extended Release 021802 03/01/2015
Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextroamphetamine Sulfate_Oral ER Cap_017078_RV03-15.pdf Draft Oral Capsule, Extended Release 017078 03/01/2015
Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextroamphetamine sulfate_oral tablet_ANDA 040361_RC05-17.pdf Draft Oral Tablet 040361 07/01/2017
Dextromethorphan Hydrobromide; Guaifenesin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextromethorphan_Hydrobromide;_Guaifenesin_ERtab_21620_RC12-08.pdf Draft Oral Tablet, Extended Release 021620 12/01/2008
Dextromethorphan Hydrobromide; Quinidine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextromethorphan_Quinidine_cap_021879_RV04-13.pdf Draft Oral Capsule 021879 04/01/2013
Dextromethorphan Polistirex https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextromethorphan_Polistirex_ERsusp_18658_RC10-05.pdf Final Oral Suspension, Extended Release 018658 05/01/2008
Diazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazepam_Rectal_gel_20648_RC08-10.pdf Draft Rectal Gel 020648 07/01/2010
Diazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazepam_draft_Oral tab_RLD 013263_RC09-18.pdf Draft Oral Tablet 013263 09/01/2018
Diazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211635.pdf Draft Nasal Spray 211635 11/18/2020
Diazoxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazoxide_oral_suspension_17453_RC02-14.pdf Draft Oral Suspension 017453 04/01/2014
Dichlorphenamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dichlorphenamide_Oral_tablets_NDA_011366_RC_Oct_2018.pdf Draft Oral Tablet 011366 11/01/2018
Diclofenac https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_oral capsule_204592_RC03-15.pdf Draft Oral Capsule 204592 03/01/2015
Diclofenac Epolamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021234.pdf Draft Topical Patch 021234 11/01/2019
Diclofenac Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Potassium_cap_22202_RC4-11.pdf Draft Oral Capsule 022202 04/01/2011
Diclofenac Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020142.pdf Draft Oral Tablet 020142 11/08/2021
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac sodium_topical solution_NDA 204623_RC05-17.pdf Draft Topical Solution 204623 07/01/2017
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_ Sodium_sol_top_20947_RC04-11.pdf Draft Topical Solution 020947 06/01/2011
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022122.pdf Draft Topical Gel 022122 10/21/2022
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021005.pdf Draft Topical Gel 021005 10/21/2022
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Sodium_DRtab_19201_74376_RC10-09.pdf Draft Oral Tablet, Delayed Release 019201 10/01/2009
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Sodium_ERtab_20254_RC10-09.pdf Draft Oral Tablet, Extended Release 020254 10/01/2009
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac sodium_ophthalmic solution_NDA 020037_RV08-17.pdf Draft Ophthalmic Solution/Drops 020037 10/01/2017
Diclofenac Sodium; Misoprostol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Sodium;_Misoprostol_ DRtab_20607_ RC2-02.pdf Draft Oral Tablet, Delayed Release 020607 12/01/2009
Dicloxacillin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dicloxacillin_cap_62286_RC6-05.pdf Final Oral Capsule 061454 05/01/2008
Dicyclomine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_007409-Tab.pdf Draft Oral Tablet 007409 11/08/2021
Dicyclomine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_007409-Cap.pdf Draft Oral Capsule 007409 02/17/2022
Didanosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Didanosine_tab_for_susp_77275_RV06-13.pdf Draft Oral Tablet, For Suspension 077275 06/01/2013
Didanosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021183.pdf Draft Oral Capsule, Delayed Release Pellets 021183 11/01/2019
Dienogest;Estradiol Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dienogest;_Estradiol_Valerate_tab_22252_RC12-10.pdf Draft Oral Tablet 022252 12/01/2010
Diethylpropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diethylpropion_ERtab_ 12546_RC12-09.pdf Draft Oral Tablet, Extended Release 012546 12/01/2009
Diflorasone Diacetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflorasone_Ointment_075331_RC07-14.pdf Draft Topical Ointment 019260 07/01/2014
Diflorasone Diacetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflorasone diacetate_topical cream_RLD 075508_RC01-16.pdf Draft Topical Cream 075508 01/01/2016
Diflorasone Diacetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflorasone diacetate_topical cream_RLD 076263_RC01-16.pdf Draft Topical Cream 076263 01/01/2016
Diflunisal https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflunisal_ oral tablet_ RLD18445_Final 08-17.pdf Final Oral Tablet 018445 08/01/2017
Difluprednate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Difluprednate_ophthalmic emulsion_RLD 022212_RV02-17.pdf Draft Ophthalmic Emulsion 022212 02/01/2017
Digoxin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Digoxin_oral tablet_NDA 020405_RV08-17.pdf Draft Oral Tablet 020405 08/01/2017
Dihydroergotamine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020148.pdf Draft Nasal Spray, Metered 020148 06/01/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019471.pdf Draft Oral Capsule, Extended Release 019471 06/01/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020092.pdf Draft Oral Capsule, Extended Release 020092 06/01/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020062.pdf Draft Oral Capsule, Extended Release 020062 06/01/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020401.pdf Draft Oral Capsule, Extended Release 020401 06/01/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021392.pdf Draft Oral Tablet, Extended Release 021392 06/01/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018602.pdf Draft Oral Tablet 018602 03/01/2020
Dimethyl Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dimethyl fumarate_DRcap_204063_RC07-14.pdf Draft Oral Capsule, Delayed Release 204063 07/01/2014
Dinoprostone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dinoprostone_Supp_Vag_017810_RC06-12.pdf Draft Vaginal Suppository 017810 06/01/2012
Dinoprostone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dinoprostone_insert_vag_ER_20411_RC11-11.pdf Draft Vaginal Insert, Extended Release 020411 11/01/2011
Dinoprostone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dinoprostone_gel_endocx_19617_RC9-11.pdf Draft Endocervical Gel 019617 09/01/2011
Diphenhydramine Citrate; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021394.pdf Draft Oral Tablet 021394 09/01/2019
Diphenhydramine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diphenhydramine HCl_ oral capsule_ ANDA 80738_Final 08-17c.pdf Final Oral Capsule 080738 08/01/2017
Diphenhydramine Hydrochloride; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diphenhydramine_HCl_Ibuprofen_caps_21393_RC06-12_OTC.pdf Draft Oral Capsule 021393 06/01/2012
Diphenhydramine Hydrochloride; Naproxen Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diphenhydramine HCL_Naproxen Sodium_Oral tab_205352_RC03-15.pdf Draft Oral Tablet 205352 03/01/2015
Dipyridamole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dipyridamole_ oral tablet_ RLD 12836_Final 08-17.pdf Final Oral Tablet 012836 08/01/2017
Diroximel Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211855.pdf Draft Oral Capsule, Delayed Release 211855 08/01/2020
Disopyramide Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017447.pdf Draft Oral Capsule 017447 11/01/2019
Disopyramide Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Disopyramide_Phosphate_ERcap_18655_RC10-08.pdf Draft Oral Capsule, Extended Release 018655 10/01/2008
Disulfiram https://www.accessdata.fda.gov/drugsatfda_docs/psg/Disulfiram_ oral tablet_ RLD 007883_Final 08-17.pdf Final Oral Tablet 007883 08/01/2017
Divalproex Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Divalproex sodium__oral DR tablet_RLD 018723_RV12-16.pdf Draft Oral Tablet, Delayed Release 018723 12/01/2016
Divalproex Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Divalproex sodium_oral DR pellets capsule_RLD 019680_RV12-16.pdf Draft Oral Capsule, Delayed Release Pellets 019680 12/01/2016
Divalproex Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Divalproex sodium__oral ER tablet_RLD 21168_RV12-16.pdf Draft Oral Tablet, Extended Release 021168 12/01/2016
Docosanol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020941.pdf Draft Topical Cream 020941 10/21/2022
Dofetilide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dofetilide_cap_20931_RC10-05.pdf Final Oral Capsule 020931 05/01/2008
Dolasetron Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dolasetron_Mesylate_tab_20623_RC5-10.pdf Draft Oral Tablet 020623 05/01/2010
Dolutegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204790.pdf Draft Oral Tablet 204790 08/01/2020
Dolutegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213983.pdf Draft Oral Tablet, For Suspension 213983 02/17/2022
Dolutegravir Sodium; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211994.pdf Draft Oral Tablet 211994 06/01/2020
Dolutegravir Sodium; Rilpivirine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210192.pdf Draft Oral Tablet 210192 08/01/2020
Donepezil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021720.pdf Draft Oral Tablet, Orally Disintegrating 021720 11/08/2021
Donepezil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil HCl_Oral Tablet_RLD 22568_Final 08-17.pdf Final Oral Tablet 022568 08/01/2017
Donepezil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil_HCl_tab_20690_RC10-05.pdf Draft Oral Tablet 020690 04/01/2010
Donepezil Hydrochloride;Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil Hydrochloride; Memantine Hydrochloride_draft_Oral cap ER_RLD 206439_RC07-18.pdf Draft Oral Capsule 206439 07/01/2018
Doravirine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210806.pdf Draft Oral Tablet 210806 03/01/2020
Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210807.pdf Draft Oral Tablet 210807 03/01/2020
Dorzolamide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/DORZOLAMIDE HYDROCHLORIDE_ophthalmic solution_NDA 020408_RV07-17.pdf Draft Ophthalmic Solution/Drops 020408 07/01/2017
Doxazosin Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxazosin mesylate_Oral tablet_RLD 19668_Final 08-17.pdf Final Oral Tablet 019668 08/01/2017
Doxazosin Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxazosin_Mesylate_ERtab_21269_RC9-06.pdf Final Oral Tablet, Extended Release 021269 05/01/2008
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxepin_HCl_Oral Capsule_RLD 16798_Final 08-17.pdf Final Oral Capsule 016798 08/01/2017
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxepin_HCl_tabs_22036_RC09-10.pdf Draft Oral Tablet 022036 09/01/2010
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxepin_HCl_Oral Capsule_70791_RV03-15.pdf Draft Oral Capsule 016798 03/01/2015
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020126.pdf Draft Topical Cream 020126 10/21/2022
Doxercalciferol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxercalciferol_oral capsule_RLD 20862_Final 08-17.pdf Final Oral Capsule 020862 08/01/2017
Doxorubicin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050718.pdf Draft Injection Injectable, Liposomal 050718 05/19/2022
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_Capsule_050641_RC07-14.pdf Draft Oral Capsule 050641 07/01/2014
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_Capsule_065055_RC07-14.pdf Draft Oral Capsule 065055 07/01/2014
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_ DRcap_50805_RC2-08.pdf Draft Oral Capsule 050805 02/01/2008
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_tab_65070_RC10-05.pdf Draft Oral Tablet 065070 01/01/2008
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_susp_50006_RC8-08.pdf Draft Oral Suspension 050006 08/01/2008
Doxycycline calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline Calcium Oral Suspension NDA 050480 RC Feb 2019.pdf Draft Oral Suspension Suspension 050480 02/01/2019
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050751.pdf Draft Periodontal System, Extended Release 050751 08/02/2022
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209844.pdf Draft Oral Tablet 209844 11/01/2019
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral capsule_RLD 208253_RC12-16.pdf Draft Oral Capsule 208253 12/01/2016
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hydate_oral tablet_205931_RC06-15.pdf Draft Oral Tablet 205931 06/01/2015
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_Hyclate_cap_50007_RC7-08.pdf Draft Oral Capsule 050007 07/01/2008
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral DR tablet_NDA 050795_RV03-18.pdf Draft Oral Tablet, Delayed Release 050795 03/01/2018
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral tablet_NDA 050783_RC11-17.pdf Draft Oral Tablet 050783 02/01/2018
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050533.pdf Draft Oral Tablet 050533 03/24/2021
Doxylamine Succinate; Pyridoxine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxylamine succinate_Pyridoxine HCl_DRtab_21876_RC07-14.pdf Draft Oral Tablet, Delayed Release 021876 07/01/2014
Doxylamine succinate; Pyridoxine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxylamine succinate and pyridoxine hydrochloride oral ER tablet NDA 209661 RC Feb 2019.pdf Draft Oral Capsule, Extended Release 209661 02/01/2019
Dronabinol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dronabinol_cap_18651_RV02-14.pdf Draft Oral Capsule 018651 02/01/2014
Dronedarone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dronedarone_Hydrochloride_Tablets_022425_RV07-14.pdf Draft Oral Tablet 022425 07/01/2014
Drospirenone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211367.pdf Draft Oral Tablet 211367 08/01/2020
Drospirenone; Estetrol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214154.pdf Draft Oral Tablet 214154 11/17/2022
Drospirenone; Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone_Estradiol_oral tablet_RLD 021355_RV01-16.pdf Draft Oral Tablet 021355 01/01/2016
Drospirenone; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone_EE_tabs_21676_RV11-13.pdf Draft Oral Tablet 021676 11/01/2013
Drospirenone; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone;_Estradiol_tab(Yazmin)_21098_RC3-09.pdf Draft Oral Tablet 021098 03/01/2009
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone_EE_Levomefolate_tab_22532_22564_RC03-12.pdf Draft Oral Tablet 022532 022574 03/01/2012
Droxidopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Droxidopa_Oral capsule_203202_RC06-15.pdf Draft Oral Capsule 203202 06/01/2015
Duloxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021427.pdf Draft Oral Capsule, Delayed Release Pellets 021427 09/01/2019
Duloxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212516.pdf Draft Oral Capsule, Delayed Release 212516 03/01/2020
Dutasteride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dutasteride_cap_21319_RC7-05.pdf Final Oral Capsule 021319 05/01/2008
Dutasteride;Tamsulosin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dutasteride_tamsulosin_HCl_cap_22460_RV02-14.pdf Draft Oral Capsule 022460 02/01/2014
Duvelisib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211155.pdf Draft Oral Capsule 211155 09/01/2019
Econazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Econazole Nitrate Topical Cream NDA 018751 RV Feb 2019.pdf Draft Topical Cream 018751 02/01/2019
Edaravone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209176.pdf Draft Intravenous Solution 209176 03/01/2020
Edoxaban Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206316.pdf Draft Oral Tablet 206316 03/01/2020
Efavirenz https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz_cap_20972_RC10-05.pdf Final Oral Capsule 020972 05/01/2008
Efavirenz https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz_tab_21360_RC11-06.pdf Final Oral Tablet 021360 05/01/2008
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz_ Emtricitabine_Tenofovir_Disoproxil_Fumarate_tab_21937_RC10-08.pdf Draft Oral Tablet 021937 10/01/2008
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz Lamivudine Tenoforvir Dsisoproxile Funarate Tablets NDA208255 PSG Page RC May 2019.pdf Draft Oral Tablet 208255 05/01/2019
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efavirenz-Lamivudine-Tenofovir Disoproxil Fumarate Oral Tablet NDA 022142 page RC May 2019.pdf Draft Oral Tablet 022142 05/01/2019
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210649.pdf Draft Oral Tablet 210649 06/01/2020
Efinaconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Efinaconazole_draft_Topical solution_RLD 203567_RC09-18.pdf Draft Topical Solution 203567 09/01/2018
Elagolix Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210450.pdf Draft Oral Tablet 210450 03/01/2020
Elbasvir; Grazoprevir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Elbasvir; Grazoprevir_ Oral Tablet_ RLD 208261_ RC09-16.pdf Draft Oral Tablet 208261 10/01/2016
Eletriptan Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eletriptan_HBr_tab_21016_RC5-09.pdf Final Oral Tablet 021016 10/01/2011
Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212273.pdf Draft Oral Tablet, Tablet 212273 03/24/2021
Eliglustat Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eliglustat tartrate_capsule_205494_RC06-15.pdf Draft Oral Capsule 205494 06/01/2015
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022291.pdf Draft Oral Tablet 022291 08/20/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207027.pdf Draft Oral For Suspension 207027 08/20/2021
Eluxadoline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eluxadoline_oral tab_RLD 206940_RC04-16.pdf Draft Oral Tablet 206940 04/01/2016
Elvitegravir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Elvitegravir_oral tablet_RLD203093_RC01-16.pdf Draft Oral Tablet 203093 01/01/2016
Empagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Empagliflozin_oral tablet_204629_RC06-15.pdf Draft Oral Tablet 204629 06/01/2015
Empagliflozin; Linagliptin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Empagliflozin; Linagliptin_oral tablet_RLD 206073_RC04-16.pdf Draft Oral Tablet 206073 04/01/2016
Empagliflozin; Linagliptin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212614.pdf Draft Oral Tablet, Extended Release 212614 08/01/2020
Empagliflozin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Empagliflozin; Metformin HCl_oral ER tablet_NDA 208658_RC08-17.pdf Draft Oral Tablet, Extended Release 208658 10/01/2017
Empagliflozin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Empagliflozin; Metformin hydrochloride_oral tab_RLD 206111_RC06-16.pdf Draft Oral Tablet 206111 06/01/2016
Emtricitabine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Emtricitabine_cap_21500_RC8-05.pdf Final Oral Capsule 021500 08/01/2010
Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Emtricitabine; Rilpivirine HCL; 208351_RV08-17.pdf Draft Oral Tablet 208351 10/01/2017
Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/EmtricitabineRilpivirineHClTenofovir disoproxil fumaratetab202123RC03-15.pdf Draft Oral Tablet 202123 03/01/2015
Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Emtricitabine_Tenofovir_208215_RV08-17.pdf Draft Oral Tablet 208215 10/01/2017
Emtricitabine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Emtricitabine; Tenofovir disoproxil fumarate_oral tablet_RLD 21752_RV03-17.pdf Draft Oral Tablet 021752 05/01/2017
Enalapril Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Enalapril_Maleate_tab_18998_RC8-08.pdf Draft Oral Tablet 018998 08/01/2008
Enasidenib mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Enasidenib mesylate_draft_Oral tab_RLD 209606_RC09-18.pdf Draft Oral Tablet 209606 09/01/2018
Encorafenib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210496.pdf Draft Oral Capsule 210496 11/01/2019
Enoxaparin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Enoxaparin_Inj_20164_RC10-11.pdf Draft Subcutaneous Injection 020164 10/01/2011
Entacapone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Entacapone_tab_020796_RV06-13.pdf Draft Oral Tablet 020796 06/01/2013
Entecavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Entecavir_tab_21797_RC5-06.pdf Final Oral Tablet 021797 05/01/2008
Entrectinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212725.pdf Draft Oral Capsule 212725 03/24/2021
Enzalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203415.pdf Draft Oral Capsule 203415 02/17/2022
Enzalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213674.pdf Draft Oral Tablet 213674 02/17/2022
Epinephrine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Epinephrine_intramuscular and subcutaneous injectable_NDA 020800_RC08-17.pdf Draft Intramuscular/Subcutaneous Injectable 020800 10/01/2017
Epinephrine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Epinephrine_intramuscular injection_RLD 19430_RC12-16.pdf Draft Intramuscular, Subcutaneous Injectable 019430 12/01/2016
Epinephrine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Epinephrine_draft_Intramuscular subcutaneous solution_RLD 207534_RC07-18.pdf Draft Intramuscular, Subcutaneous Solution 207534 07/01/2018
Epinephrine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205920.pdf Draft Inhalation Aerosol, Metered 205920 11/18/2020
Eplerenone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eplerenone_tab_21437_RC3-05.pdf Final Oral Tablet 021437 05/01/2008
Eprosartan Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eprosartan Mesylate_Oral Tablet_RLD 020738_Final 08-17.pdf Final Oral Tablet 020738 08/01/2017
Eprosartan Mesylate; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eprosartan_Mesylate;_HCTZ_tab_21268_RC2-08.pdf Draft Oral Tablet 021268 02/01/2008
Eravacycline Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ERAVACYCLINE DIHYDROCHLORIDE POWDER INTRAVENOUS NDA 211109 PSG Page RC May 2019.pdf Draft Intravenous Powder 211109 05/01/2019
Erdafitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212018.pdf Draft Oral Tablet 212018 08/01/2020
Ergocalciferol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ergocalciferol_Caps_003444_RV07-14.pdf Draft Oral Capsule 003444 07/01/2014
Erlotinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erlotinib_HCl_tab_21743_RC1-06.pdf Final Oral Tablet 021743 05/01/2008
Ertugliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ertugliflozin_Oral tablet_NDA 209803_RC Oct 2018.pdf Draft Oral Tablet 209803 11/01/2018
Ertugliflozin; Metformin hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ertugliflozin; Metformin Hydrochloride_Oral tablet_NDA 209806_RC Oct 2018.pdf Draft Oral Tablet 209806 11/01/2018
Ertugliflozin; Sitagliptin phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ertugliflozin; Sitagliptin Phosphateoral_Oral tablet_NDA 209805_RC Oct 2018.pdf Draft Oral Tablet 209805 11/01/2018
Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050617.pdf Draft Topical Gel 050617 10/21/2022
Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_DRtab_62298_RC02-14.pdf Draft Oral Tablet, Delayed Release 062298 04/01/2014
Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_ophthalmic ointment_RLD 062447_RV09-16.pdf Draft Ophthalmic Ointment 062447 10/01/2016
Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_SolTopical_ 64187_RC2-10.pdf Draft Topical Solution 064187 02/01/2010
Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_swab_64126_RC2-10.pdf Draft Topical Swab 064126 02/01/2010
Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Erythromycin_oral tablet_RLD 061621_RC01-16.pdf Draft Oral Tablet 061621 01/01/2016
Erythromycin Ethylsuccinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_061904.pdf Draft Oral Tablet 061904 061905 11/18/2020
Erythromycin Ethylsuccinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050207.pdf Draft Oral Granule 050207 11/18/2020
Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050529.pdf Draft Oral Granule 050529 11/18/2020
Escitalopram Oxalate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Escitalopram_Oxalate_cap_77660_RC9-08.pdf Draft Oral Capsule 077660 09/01/2008
Escitalopram Oxalate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Escitalopram_Oxalate_tab_21323_RC10-05.pdf Final Oral Tablet 021323 05/01/2008
Esketamine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211243.pdf Draft Nasal Spray 211243 08/01/2020
Eslicarbazepine Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eslicarbazepine acetate_oral tablet_022416_RC09-15.pdf Draft Oral Tablet 022416 09/01/2015
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole magnesium_oral DR tablet_NDA 207920_RV08-17.pdf Draft Oral Tablet, Delayed Release 207920 10/01/2017
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole magnesium_oral DR suspension_NDA 021957 and 022101_RV11-17.pdf Draft Oral Powder For Suspension, Delayed Release 021957 022101 02/01/2018
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole magnesium_oral DR capsule pellets_NDA 021153_RV11-17.pdf Draft Oral Capsule, Delayed Release Pellets 021153 02/01/2018
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204655.pdf Draft Oral Capsule, Delayed Release 204655 08/01/2020
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214278.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/20/2021
Esomeprazole Magnesium; Naproxen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole_Mag;_Naproxen_DRtab_22511_RC03-11.pdf Draft Oral Tablet, Delayed Release 022511 03/01/2011
Esomeprazole Strontium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esomeprazole Strontium_draft_Oral cap DR_RLD 202342_RC07-18.pdf Draft Oral Capsule, Delayed Release 202342 07/01/2018
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol_tabs_84500_84499_81295_RC_12-10.pdf Draft Oral Tablet 081295 084499 084500 12/01/2010
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203752.pdf Draft Transdermal Film, Extended Release 203752 11/01/2019
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019081.pdf Draft Transdermal Film, Extended Release 019081 11/01/2019
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020375.pdf Draft Transdermal Film, Extended Release 020375 021674 11/01/2019
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020538.pdf Draft Transdermal Film, Extended Release 020538 11/01/2019
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol_vaginal_crm_86069_RV09-14.pdf Draft Vaginal Cream 086069 09/01/2014
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estradiol_vaginal_tablet_20908_ 08-09.pdf Draft Vaginal Tablet 020908 03/01/2011
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021813.pdf Draft Transdermal Gel, Metered 021813 02/17/2022
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022014.pdf Draft Transdermal Spray 022014 02/17/2022
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022038.pdf Draft Transdermal Gel 022038 02/01/2022
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021166.pdf Draft Transdermal Gel, Metered 021166 08/20/2021
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020472.pdf Draft Vaginal Insert, Extended Release 020472 06/01/2020
Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021258.pdf Draft Transdermal Film, Extended Release 021258 11/01/2019
Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norethindrone_Acetate_(Activella)_tab_20907_RC3-09.pdf Draft Oral Tablet 020907 03/01/2009
Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020870.pdf Draft Transdermal Film, Extended Release 020870 11/01/2019
Estramustine Phosphate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estramustine_Caps_018045_RC04-13.pdf Draft Oral Capsule 018045 04/01/2013
Estrogen; Esterified https://www.accessdata.fda.gov/drugsatfda_docs/psg/Esterified estrogen_84948_RC09-12.pdf Draft Oral Tablet 084948 084949 084950 084951 09/01/2012
Estrogens, Conjugated https://www.accessdata.fda.gov/drugsatfda_docs/psg/Conjugated_estrogens_004782_RC12-14.pdf Draft Oral Tablet 004782 12/01/2014
Estrogens; Conjugated Synthetic A https://www.accessdata.fda.gov/drugsatfda_docs/psg/Estrogens_Conjugated_Synthetic_A_tabs_20992_RC04-10.pdf Draft Oral Tablet 020992 04/01/2010
Eszopiclone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Eszopiclone_tab_21476.pdf Draft Oral Tablet 021476 01/01/2008
Etelcalcetide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208325.pdf Draft Intravenous Solution 208325 02/17/2022
Eteplirsen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206488.pdf Draft Intravenous Solution 206488 11/17/2022
Ethacrynic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethacrynic_acid_tab_16092_RC12-10.pdf Draft Oral Tablet 016092 12/01/2010
Ethambutol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethambutol HCl_oral tablet_RLD 016320_Final 08-17.pdf Final Oral Tablet 016320 08/01/2017
Ethinyl Estradiol; Ethynodiol Diacetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Ethynodiol_Diacetate_(Zovia)_tab_72723_72721_RC10-09.pdf Draft Oral Tablet 072721 072723 12/01/2009
Ethinyl Estradiol; Etonogestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol_Etonogestrel_vaginal_ring_21187_RC04-13.pdf Draft Vaginal Ring 021187 04/01/2013
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_estradiol_Levonorgestrel_tab_204061_RV12-14.pdf Draft Oral Tablet 021544 021840 022262 204061 12/01/2014
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradio;_Levonorgestrel_(Trivora)_tab_74538_RC11-09.pdf Draft Oral Tablet 019190 019192 11/01/2009
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Levonorgestrel_tab_21864_RC4-09.pdf Draft Oral Tablet 021864 04/01/2009
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Levonorgestrel_(Nordette)_tab_18782_RC3-09.pdf Draft Oral Tablet 018782 03/01/2009
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Levonorgestrel_tab_76625_RC3-09.pdf Draft Oral Tablet 020683 03/01/2009
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Levonorgestrel_(Levite)_20860_RC10-08.pdf Draft Oral Tablet 020860 10/01/2008
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208612.pdf Draft Oral Tablet 208612 03/24/2021
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209405.pdf Draft Oral Tablet 209405 03/24/2021
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204017.pdf Draft Transdermal System 204017 08/20/2021
Ethinyl Estradiol; Norelgestromin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021180.pdf Draft Transdermal Film, Extended Release 200910 021180 11/01/2019
Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol_Norethindone_chewtab_22573_RC03-12.pdf Draft Oral Tablet, Chewable 022573 03/01/2012
Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl estradiol and Norethindrone_oral tablets_203006 and 200897 _RV09-15.pdf Draft Oral Tablet 200897 203006 09/01/2015
Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norethindrone_(Trinorinyl)_tab_18977_RC11-09.pdf Draft Oral Tablet 018977 11/01/2009
Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021490.pdf Draft Oral Tablet 021490 202086 08/02/2022
Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol_Norethindrone__Orthonovum__tab_17919_18985_RC05-09.pdf Draft Oral Tablet 017735 017919 018985 12/01/2010
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol_Norethindrone_LoLoestrin_22501_RC06-11.pdf Draft Oral Tablet 022501 06/01/2011
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/EE;NorethindroneAcetate(Loestrin)tab17355_17875_17354_17876_21871RC10-09.pdf Draft Oral Tablet 017354 017355 021871 10/01/2009
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norethindrone_Acetate_(Estrostep)_tab_20130_RC7-08.pdf Draft Oral Tablet 020130 07/01/2008
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021065.pdf Draft Oral Tablet 021065 11/17/2022
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl estradiol_Norethindrone acetate_oral tablet_RLD204654_RC01-16.pdf Draft Oral Tablet, Chewable 204654 01/01/2016
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203667.pdf Draft Oral Tablet 203667 08/02/2022
Ethinyl estradiol; Norethindrone acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl estradiol; Norethindrone acetate_draft_Oral cap_RLD 204426_RC07-18.pdf Draft Oral Capsule 204426 07/01/2018
Ethinyl Estradiol; Norgestimate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norgestimate_tab _19653_19697_21241_RC12-09.pdf Draft Oral Tablet 019653 019697 021241 12/01/2009
Ethinyl Estradiol; Norgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethinyl_Estradiol;_Norgestrel_(Ogestrel)_tab_75406_75288_RC10-09.pdf Draft Oral Tablet 075288 075406 10/01/2009
Ethiodized Oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethiodized Oil_intralymphatic intrauterine oil_RLD 009190_RC12-16.pdf Draft Intralymphatic, Intrauterine, Selective Hepatic Intra-arterial Injectable 009190 12/01/2016
Ethionamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethionamide_tab_13026_RC04-13.pdf Draft Oral Tablet 013026 04/01/2013
Ethosuximide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ethosuximide_draft_Oral cap_RLD 012380_RC07-18.pdf Draft Oral Capsule 012380 07/01/2018
Etidronate Disodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etidronate_Disodium_tab_17831_RC10-05.pdf Final Oral Tablet 017831 05/01/2008
Etodolac https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etodolac_cap_75078_RC11-13.pdf Draft Oral Capsule 018922 11/01/2013
Etodolac https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etodolac_tab_75074_RC11-13.pdf Draft Oral Tablet 018922 11/01/2013
Etodolac https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etodolac_ERtabs_75665_RC07-10.pdf Draft Oral Tablet, Extended Release 020584 07/01/2010
Etonogestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021529.pdf Draft Implantation Implant 021529 08/02/2022
Etoposide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etoposide_caps_75635_RC08-10.pdf Draft Oral Capsule 075635 08/01/2010
Etravirine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Etravirine_tab_22187_RC09-12.pdf Draft Oral Tablet 022187 09/01/2012
Everolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/Everolimus_oral tablet for suspension_NDA 203985_RC08-17.pdf Draft Oral Tablet, For Suspension 203985 10/01/2017
Everolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/Everolimus_draft_Oral tab_RLD 22334_RC11-18.pdf Draft Oral Tablet 022334 11/01/2018
Everolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021560.pdf Draft Oral Tablet 021560 06/01/2020
Exemestane https://www.accessdata.fda.gov/drugsatfda_docs/psg/Exemestane_tab_20753_RC10-05.pdf Final Oral Tablet 020753 05/01/2008
Exenatide Synthetic https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022200.pdf Draft Subcutaneous For Suspension, Extended Release 022200 05/19/2022
Exenatide Synthetic https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209210.pdf Draft Subcutaneous Suspension, Extended Release 209210 05/19/2022
Ezetimibe https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ezetimibe_tab_21445_RC10-08.pdf Draft Oral Tablet 021445 10/01/2008
Ezetimibe; Simvastatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ezetimibe;_Simvastatin_tab_21687_RC9-08.pdf Draft Oral Tablet 021687 09/01/2008
Ezogabine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ezogabine_tab_22345_RC04-13.pdf Draft Oral Tablet 022345 04/01/2013
Famciclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famciclovir_tab_20363_RC8-08.pdf Draft Oral Tablet 020363 08/01/2008
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famotidine_sus_19527_RC12-08.pdf Draft Oral Suspension 019527 12/01/2008
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famotidine_ODtab_21712_RC11-06.pdf Final Oral Tablet, Orally Disintegrating 021712 05/01/2008
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famotidine_tab_19462_RC10-05.pdf Final Oral Tablet 019462 020325 05/01/2008
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020801.pdf Draft Oral Tablet, Chewable 020801 08/02/2022
Famotidine; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Famotidine; Ibuprofen_Tab_22519_RC06-12.pdf Draft Oral Tablet 022519 06/01/2012
Febuxostat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Febuxostat_tab_21856_RC2-10.pdf Draft Oral Tablet 021856 02/01/2010
Fedratinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212327.pdf Draft Oral Capsule 212327 03/24/2021
Felbamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Felbamate_oral suspension_NDA 020189_RV11-17.pdf Draft Oral Suspension 020189 02/01/2018
Felbamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Felbamate_oral tablet_NDA 020189_RV11-17.pdf Draft Oral Tablet 020189 02/01/2018
Felodipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Felodipine_ERtab_78855_RC12-09.pdf Draft Oral Tablet, Extended Release 019834 12/01/2009
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_oral capsule_RLD 021695 (90 and 30 mg)_RC12-16.pdf Draft Oral Capsule 021695 12/01/2016
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_tab_76433_RC03-12.pdf Draft Oral Tablet 021203 03/01/2012
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_cap_75753_RC2-10.pdf Draft Oral Capsule 019304 02/01/2010
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_tab_22118_RC9-08.pdf Draft Oral Tablet 022118 09/01/2008
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_cap_21612_RC2-08.pdf Draft Oral Capsule 021612 02/01/2008
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_cap_21695_RC11-06.pdf Final Oral Capsule 021695 05/01/2008
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_tab_21656_RC3-02.pdf Final Oral Tablet 021656 05/01/2008
Fenofibrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibrate_tab_21350_RC10-08.pdf Draft Oral Tablet 021350 10/01/2008
Fenofibric Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fenofibric_Acid_tabs_22418_RC08-10.pdf Draft Oral Tablet 022418 08/01/2010
Fenoprofen Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017604.pdf Draft Oral Capsule 017604 03/24/2021
Fentanyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_Sublingual spray_202788_RC06-15.pdf Draft Sublingual Spray 202788 06/01/2015
Fentanyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019813.pdf Draft Transdermal Film, Extended Release 019813 11/01/2019
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_citrate_nasal_22569_RC02-14.pdf Draft Nasal Spray, Metered 022569 04/01/2014
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_citrate_subltab_22510_RC09-12.pdf Draft Sublingual Tablet 022510 09/01/2012
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_Citrate_TroLoz_20747_RC2-10.pdf Draft Transmucosal Troche/Lozenge 020747 02/01/2010
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fentanyl_citrate_tablet_buccal_21947_RV06-13.pdf Draft Buccal, Sublingual Tablet 021947 06/01/2013
Ferric Carboxymaltose https://www.accessdata.fda.gov/drugsatfda_docs/psg/FERRIC CARBOXYMALTOSE_injection_RLD 203565_RC04-16.pdf Draft Intravenous Injectable 203565 04/01/2016
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/01/2021
Ferric Maltol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212320.pdf Draft Oral Capsule 212320 03/24/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205109.pdf Draft Oral Tablet, Chewable 205109 09/01/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021135.pdf Draft Intravenous Injectable 021135 09/01/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020955.pdf Draft Injection Injectable 020955 11/17/2022
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017441.pdf Draft Injection Injectable 017441 11/17/2022
Ferumoxytol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ferumoxytol_ivsol_22180_RC12-12.pdf Draft Intravenous Injection 022180 12/01/2012
Fesoterodine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fesoterodine_Fumarate_ERtab_22030_RC11-10.pdf Draft Oral Tablet, Extended Release 022030 11/01/2010
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine_Hydrochloride_susp_21963_RC12-08.pdf Draft Oral Suspension 021963 12/01/2008
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine_HCl_ODtab_21909_RC8-08.pdf Draft Oral Tablet, Orally Disintegrating 021909 08/01/2008
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine_HCl_cap_20625_RC1-04.pdf Draft Oral Capsule 020625 07/01/2009
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine_HCl_tab_76191_RC2-01.pdf Draft Oral Tablet 020872 09/01/2008
Fexofenadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_201373.pdf Draft Oral Suspension 201373 09/01/2019
Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fexofenadine;_Pseudoephedrine_ERtab_20786_21704_RC10-09.pdf Draft Oral Tablet, Extended Release 020786 021704 10/01/2009
Fidaxomicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/fidaxomicin_oral tablet_RLD 201699_RC08-16 separate posting.pdf Draft Oral Tablet 201699 08/01/2016
Fidaxomicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213138.pdf Draft Oral For Suspension 213138 11/17/2022
Finafloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Finafloxacin_otic suspension drops_NDA 206307_RC07-18.pdf Draft Otic Suspension/Drops 206307 07/01/2018
Finasteride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Finasteride_tab_20180_20788_RC1-11.pdf Draft Oral Tablet 020180 020788 01/01/2011
Fingolimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022527.pdf Draft Oral Capsule 022527 09/01/2019
Fish Oil Triglycerides https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210589.pdf Draft Intravenous Emulsion 210589 06/01/2020
Fish oil; Medium chain triglycerides; Olive oil; Soybean oil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fish oil; Medium chain triglycerides; Olive oil; Soybean oil NDA 207648 Feb 2019.pdf Draft Intravenous Emulsion 207648 02/01/2019
Flavoxate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016769.pdf Draft Oral Tablet 016769 11/01/2019
Flecainide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flecainide_tab_18830_RC2-10.pdf Draft Oral Tablet 018830 02/01/2010
Flibanserin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flibanserin_oral tablet_RLD 22526_RC06-16.pdf Draft Oral Tablet 022526 06/01/2016
Flortaucipir F-18 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212123.pdf Draft Intravenous Solution 212123 02/17/2022
Fluconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluconazole_oral tablet_NDA 019949_RV11-17.pdf Draft Oral Tablet 019949 02/01/2018
Flucytosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flucytosine_cap_17001_RC07-10.pdf Draft Oral Capsule 017001 07/01/2010
Fludarabine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fludarabine_tab_22273_RC03-12.pdf Draft Oral Tablet 022273 03/01/2012
Fludrocortisone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fludrocortisone_Acetate_tab_40431_RC8-09.pdf Final Oral Tablet 010060 10/01/2011
Flunisolide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018148.pdf Draft Nasal Spray, Metered 018148 05/19/2022
Fluocinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012787.pdf Draft Topical Cream 012787 10/21/2022
Fluocinolone Acetonide; Hydroquinone; Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinolone_Acetonide_Hydroquinone_Tretinoin_crm_21112_RC03-15.pdf Draft Topical Cream 021112 03/01/2015
Fluocinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinonide_topical cream_RLD 21758_RC12-16.pdf Draft Topical Cream 021758 12/01/2016
Fluocinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinonide_topical gel_RLD 074935_RC06-16.pdf Draft Topical Gel 017373 06/01/2016
Fluocinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinonide_topical ointment_RLD 075008_RC 06-16.pdf Draft Topical Ointment 016909 06/01/2016
Fluocinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluocinonide_topical cream_NDA 019117_RC11-17.pdf Draft Topical Cream 019117 02/01/2018
Fluorodopa F-18 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200655.pdf Draft Intravenous Solution 200655 11/18/2020
Fluoroestradiol F-18 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212155.pdf Draft Intravenous Solution 212155 02/17/2022
Fluorometholone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorometholone_ophthalmic suspension_NDA 016851_RC08-17.pdf Draft Ophthalmic Suspension/Drops 016851 10/01/2017
Fluorometholone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019216.pdf Draft Ophthalmic Suspension/Drops 019216 06/01/2020
Fluorometholone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019079.pdf Draft Ophthalmic Suspension/Drops 019079 09/01/2019
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022259.pdf Draft Topical Cream 022259 10/21/2022
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016988.pdf Draft Topical Cream 016988 10/21/2022
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil_sol5_16831_RC03-11.pdf Draft Topical Solution 5% 016831 06/01/2011
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil_sol2_16831_RC03-11.pdf Draft Topical Solution 2% 016831 06/01/2011
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluorouracil Topical Cream NDA 020985 RV Feb 2019.pdf Draft Topical Cream 020985 02/01/2019
Fluorouracil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016831-Cre.pdf Draft Topical Cream 016831 10/21/2022
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine hcl_oral tablet_RLD 202133_RC12-16.pdf Draft Oral Tablet 202133 12/01/2016
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_tab_21860_RC2-11.pdf Draft Oral Tablet 021860 02/01/2011
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_tab_75755_RC2-11.pdf Draft Oral Tablet 020974 02/01/2011
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_DRcap_21235_RC08-10.pdf Draft Oral Capsule, Delayed Release 021235 08/01/2010
Fluoxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_cap_18936_RC06-13.pdf Draft Oral Capsule 018936 06/01/2013
Fluoxetine Hydrochloride; Olanzapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluoxetine_HCl_Olanzapine_cap_21520_RC8-05.pdf Draft Oral Capsule 021520 07/01/2009
Fluphenazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011751.pdf Draft Oral Tablet 011751 089743 11/18/2020
Flurandrenolide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flurandrenolide_topical lotion_RLD 013790_RC01-16.pdf Draft Topical Lotion 013790 01/01/2016
Flutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Flutamide_Caps_075780_RC04-13.pdf Draft Oral Capsule 018554 04/01/2013
Fluticasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone furoate_inhalation powder_RLD 205625_RC04-16.pdf Draft Inhalation Powder 205625 04/01/2016
Fluticasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022051.pdf Draft Nasal Spray, Metered 022051 06/01/2020
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf Draft Inhalation Powder 209482 05/19/2021
Fluticasone Furoate; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone furoate; Vilanterol trif_inhal_ pow_204275_RC04-16.pdf Draft Inhalation Powder 204275 04/01/2016
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone propionate metered inhalation aerosol NDA 021433 RV 07-2018.pdf Draft Inhalation Aerosol, Metered 021433 07/01/2018
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone proprionate_inhalation powder_NDA 020833_RC10-17.pdf Draft Inhalation Powder 020833 10/01/2017
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone propionate_topical ointment_RLD 19957_RC09-16.pdf Draft Topical Ointment 019957 10/01/2016
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone_Propionate_crm_19958_RC2-11.pdf Draft Topical Cream 019958 02/01/2011
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020121.pdf Draft Nasal Spray, Metered 020121 06/01/2020
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205434.pdf Draft Nasal Spray, Metered 205434 05/01/2021
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone Propionate Inhalation Powder NDA 208798 PSG Page RC May 2019.pdf Draft Inhalation Powder 208798 05/01/2019
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf Draft Inhalation Powder 208799 09/01/2019
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021254.pdf Draft Inhalation Aerosol, Metered 021254 06/01/2020
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluticasone Proprionate_Salmeterol Xinafoate_21077_RC09-13.pdf Draft Inhalation Powder 021077 09/01/2013
Fluvastatin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluvastatin_Sodium_cap_20261_RC1-08.pdf Draft Oral Capsule 020261 01/01/2008
Fluvastatin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluvastatin_Sodium_ERtab_21192_RC1-08.pdf Draft Oral Tablet, Extended Release 021192 01/01/2008
Fluvoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fluvoxamine_Maleate_ERCaps_22033_RC2-11.pdf Draft Oral Capsule, Extended Release 022033 02/01/2011
Formoterol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Formoterol fumarate_Inhalation powder_020831_RC09-15.pdf Draft Inhalation Powder 020831 09/01/2015
Formoterol Fumarate; Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Formoterol fumarate_Mometasone furoate_inhalation aerosol_RLD 022518_RC01-16.pdf Draft Inhalation Aerosol, Metered 022518 01/01/2016
Fosamprenavir Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosamprenavir_Calcium_susp_22116_RC11-07.pdf Draft Oral Suspension 022116 11/01/2007
Fosamprenavir Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosamprenavir_Calcium_tab_21548_RC3-05.pdf Final Oral Tablet 021548 05/01/2008
Fosdenopterin Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214018.pdf Draft Intravenous Powder 214018 11/17/2022
Fosfomycin Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosfomycin Tromethamine Oral Solution NDA 050717 PSG Page RV May 2019.pdf Draft Oral For Solution 050717 05/01/2019
Fosinopril Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosinopril_Sodium_tab_19915_RC5-07.pdf Draft Oral Tablet 019915 05/01/2008
Fosinopril Sodium; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosinopril_Sodium_HCTZ_tab_20286_RC8-05.pdf Draft Oral Tablet 020286 09/01/2008
Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fosnetupitant and Palonosetron Hydrochloride, powder for injection NDA 210493 PSG Page RC May 2019.pdf Draft Intravenous Powder 210493 05/01/2019
Fostamatinib Disodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209299.pdf Draft Oral Tablet 209299 09/01/2019
Fostemsavir Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212950.pdf Draft Oral Tablet, Extended Release 212950 08/20/2021
Frovatriptan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Frovatriptan_Succinate_tab_21006_RC10-08.pdf Draft Oral Tablet 021006 10/01/2008
Fulvestrant https://www.accessdata.fda.gov/drugsatfda_docs/psg/Fulvestrant_inj_21344_RC03-12.pdf Draft Injection, Intramuscular Solution 021344 03/01/2012
Furosemide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Furosemide_Tab_16273_RC09-10.pdf Draft Oral Tablet 016273 09/01/2010
Gabapentin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gabapentin_Oral tablet_22544_RV09-15.pdf Draft Oral Tablet 022544 09/01/2015
Gabapentin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gabapentin_cap_20235_RC3-05.pdf Draft Oral Capsule 020235 05/01/2007
Gabapentin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gabapentin_tab_20882_RC10-05.pdf Final Oral Tablet 020882 05/01/2008
Gabapentin Enacarbil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gabapentin_Enacarbil_ERtab_022399_RC06-12.pdf Draft Oral Tablet, Extended Release 022399 06/01/2012
Galantamine Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Galantamine_HBr_Tab_21169_RC11-10.pdf Draft Oral Tablet 021169 11/01/2010
Galantamine Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Galantamine_HBr_ERcap_21615_RC11-051.pdf Draft Oral Capsule, Extended Release 021615 05/01/2007
Gallium DOTATOC Ga 68 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210828.pdf Draft Intravenous Solution 210828 08/01/2020
Gallium Ga-68 Gozetotide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212642.pdf Draft Intravenous Solution 212642 212643 08/02/2022
Ganciclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ganciclovir cap 19661 RC5-03.pdf Draft Oral Capsule 020460 08/01/2007
Gatifloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gatifloxacin_ophthalmic solution drops_NDA 021493_RV11-17.pdf Draft Ophthalmic Solution 0.3% 021493 02/01/2018
Gefitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206995.pdf Draft Oral Tablet 206995 02/17/2022
Gemfibrozil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gemfibrozil_ tab_18422_RC12-09.pdf Draft Oral Tablet 018422 12/01/2009
Gemifloxacin Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gemifloxacin_Mesylate_tab_21158_RC3-06.pdf Final Oral Tablet 021158 05/01/2008
Gentamicin Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060462.pdf Draft Topical Cream 062307 10/21/2022
Gentamicin Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060463.pdf Draft Topical Ointment 062351 10/21/2022
Gentamicin Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Gentamicin sulfate_ophthalmic solution drops_NDA 050039_RV11-17.pdf Draft Ophthalmic Solution 050039 02/01/2018
Gilteritinib Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211349.pdf Draft Oral Tablet 211349 06/01/2020
Glasdegib Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210656.pdf Draft Oral Tablet 210656 08/01/2020
Glatiramer Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glatiramer acetate_subcutaneous Injection_NDA 020622_RV07-18.pdf Draft Subcutaneous Injection 020622 07/01/2018
Glecaprevir; Pibrentasvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glecaprevir Pibrentasvir Oral Tablet NDA 209394 RC 09-2018.pdf Draft Oral Tablet 209394 09/01/2018
Glimepiride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glimepiride_tab_20496_RC11-04.pdf Final Oral Tablet 020496 05/01/2008
Glimepiride; Pioglitazone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glimepiride;_Pioglitazone_tab_21925_RC5-09.pdf Final Oral Tablet 021925 10/01/2011
Glimepiride; Rosiglitazone Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glimepiride_Rosiglitazone_tab_21700_RC11-07.pdf Draft Oral Tablet 021700 11/01/2007
Glipizide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glipizide_tab_17783_RC08-10.pdf Draft Oral Tablet 017783 08/01/2010
Glipizide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glipizide_ERtab_20329_RC7-08.pdf Draft Oral Tablet, Extended Release 020329 07/01/2008
Glipizide; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glipizide_Metformin_HCl_tab_21460_RC10-05.pdf Final Oral Tablet 021460 05/01/2008
Glucagon https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212097.pdf Draft Subcutaneous Solution 212097 11/08/2021
Glyburide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glyburide_tab_20051_RC03-12.pdf Draft Oral Tablet 020051 03/01/2012
Glyburide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glyburide_tab_74388_RC03-12.pdf Draft Oral Tablet 017532 074388 03/01/2012
Glyburide; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glyburide_Metformin_tab_21178_RC3-03.pdf Draft Oral Tablet 021178 12/01/2009
Glycopyrrolate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glycopyrrolate_Inhalation Powder_NDA 207923_RC05-17.pdf Draft Inhalation Powder 207923 07/01/2017
Glycopyrrolate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Glycopyrrolate_tab_12827_RC11-09.pdf Draft Oral Tablet 012827 11/01/2009
Glycopyrrolate; Indacaterol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207930.pdf Draft Inhalation Powder 207930 06/01/2020
Glycopyrronium Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210361.pdf Draft Topical Cloth 210361 09/01/2019
Goserelin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020578.pdf Draft Implantation Implant 020578 11/17/2022
Goserelin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019726.pdf Draft Implantation Implant 019726 11/17/2022
Granisetron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022445.pdf Draft Subcutaneous Injection, Extended Release 022445 03/01/2020
Granisetron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022198.pdf Draft Transdermal Film, Extended Release 022198 11/01/2019
Granisetron Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Granisetron_HCl_tab_20305_RC2-06.pdf Draft Oral Tablet 020305 08/01/2010
Griseofulvin Microsize https://www.accessdata.fda.gov/drugsatfda_docs/psg/Griseofulvin_Microcrystalline_Susp_62483_RC11-10.pdf Draft Oral Suspension 062483 11/01/2010
Griseofulvin Ultramicrosize https://www.accessdata.fda.gov/drugsatfda_docs/psg/Griseofulvin,_Ultramicrocrystalline_tab_50475_RC10-08.pdf Draft Oral Tablet 050475 10/01/2008
Griseofulvin; Microcrystalline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Griseofulvin_tab_62279_RC2-10.pdf Draft Oral Tablet 062279 02/01/2010
Guaifenesin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Guaifenesin_ERtab_21282_RC02-14.pdf Draft Oral Tablet, Extended Release 021282 04/01/2014
Guaifenesin; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Guaifenesin;_Pseudoephedrine_HCl_ERtab_21585_RC12-08.pdf Draft Oral Tablet, Extended Release 021585 12/01/2008
Guanfacine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Guanfacine hydrochloride_oral ER tablet_022037_RV01-16.pdf Draft Oral Tablet, Extended Release 022037 01/01/2016
Guanfacine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019032.pdf Draft Oral Tablet 019032 03/24/2021
Halcinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halcinonide_topical cream_RLD 017556_RC12-16.pdf Draft Topical Cream 017556 12/01/2016
Halcinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halcinonide topical ointment NDA 017824 PSG Page RC May 2019.pdf Draft Topical Ointment 017824 05/01/2019
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209355.pdf Draft Topical Lotion 209355 10/21/2022
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halobetasol_topical lotion_RLD 208183_RC 09-16.pdf Draft Topical Lotion 208183 10/01/2016
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halobetasol propionate_topical cream_NDA 19967_RC04-16.pdf Draft Topical Cream 019967 04/01/2016
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halobetasol propionate_topical ointment_NDA 19968_RC04-16.pdf Draft Topical Ointment 019968 04/01/2016
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210566.pdf Draft Topical Aerosol, Foam 210566 05/19/2022
Haloperidol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Haloperidol Oral Tablets NDA 015921 RV Feb 2019.pdf Draft Oral Tablet 015921 02/01/2019
Heparin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017029.pdf Draft Injection Injectable 017029 019952 017007 017037 201370 018916 019953 017651 088100 02/17/2022
Homatropine Methylbromide; Hydrocodone Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Homatropine_Methylbromide;_Hydrocodone_Bitartrate_tabs_88508_RC12-09.pdf Draft Oral Tablet 005213 12/01/2009
Hydralazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydralazine_tab_89098_89097_88467_88468_RC7-08.pdf Draft Oral Tablet 008303 07/01/2008
Hydralazine Hydrochloride; Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydralazine;_Isosorbide_tab_20727_RC12-09.pdf Draft Oral Tablet 020727 12/01/2009
Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_tab_40735_RC5-10.pdf Draft Oral Tablet 011835 05/01/2010
Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_cap_20504_RC11-05.pdf Final Oral Capsule 020504 05/01/2008
Hydrochlorothiazide; Lisinopril https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_lisinopril_tab_19888_RV12-12.pdf Draft Oral Tablet 019888 019778 12/01/2012
Hydrochlorothiazide; Losartan Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide; Losartan potassium_oral tablet_RLD 20387_Final 08-17.pdf Final Oral Tablet 020387 08/01/2017
Hydrochlorothiazide; Metoprolol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metoprolol_Tartrate;_HCTZ_tab_18303_RC08-10.pdf Draft Oral Tablet 018303 08/01/2010
Hydrochlorothiazide; Moexipril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_Moexipril_HCl_Tablets_020729_RV07-14.pdf Draft Oral Tablet 020729 07/01/2014
Hydrochlorothiazide; Olmesartan Medoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Olmesartan_tab_21532_RC7-06.pdf Final Oral Tablet 021532 05/01/2008
Hydrochlorothiazide; Quinapril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide;_Quinapril_HCl_tabs_20125_RC07-10.pdf Draft Oral Tablet 020125 07/01/2010
Hydrochlorothiazide; Spironolactone https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Spironolactone_tabs_12616_RC12-09.pdf Draft Oral Tablet 012616 12/01/2009
Hydrochlorothiazide; Telmisartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Telmisartan_tab_21162_RC7-08.pdf Draft Oral Tablet 021162 07/01/2008
Hydrochlorothiazide; Triamterene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_triamterene_tab_19129_RC06-13.pdf Draft Oral Tablet 019129 06/01/2013
Hydrochlorothiazide; Triamterene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide triamterene_oral capsule_RLD 016042, 073191_Final 08-17.pdf Final Oral Capsule 016042 073191 08/01/2017
Hydrochlorothiazide; Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide; Valsartan_Oral Tablet_RLD 20818_Final 08-17.pdf Final Oral Tablet 020818 08/01/2017
Hydrochlorothiazide;Irbesartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Irbesartan_tab_20758_RC6-06.pdf Draft Oral Tablet 020758 03/01/2012
Hydrochlorothiazide;Metoprolol Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Metoprolol_succinate_ERtab_21956_RC02-14.pdf Draft Oral Tablet, Extended Release 021956 04/01/2014
Hydrocodone Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocodone bitartrate_oral ER cap_RLD 202880_RC09-16.pdf Draft Oral Capsule, Extended Release 202880 10/01/2016
Hydrocodone Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocodone bitartrate_oral ER tablet_NDA 206627_RV07-18.pdf Draft Oral Tablet, Extended Release 206627 07/01/2018
Hydrocodone Bitartrate; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/HYDROCODONE BITARTRATE; IBUPROFEN_oral tablet_RLD 020716_Final 08-17.pdf Final Oral Tablet 020716 08/01/2017
Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009585.pdf Draft Topical Cream 089414 10/21/2022
Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone_topical solution_RLD 81271_RC06-16.pdf Draft Topical Solution 081271 06/01/2016
Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone_ oral tablet_ RLD 008697_Final 08-17.pdf Final Oral Tablet 008697 08/01/2017
Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016199.pdf Draft Rectal Enema 016199 11/17/2022
Hydrocortisone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017351.pdf Draft Rectal Aerosol, Metered 017351 11/18/2020
Hydrocortisone Butyrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone butyrate_topical lotion_RLD 022076_RC03-17.pdf Draft Topical Lotion 022076 05/01/2017
Hydrocortisone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone valerate_topical ointment_RLD 070543_RC09-16.pdf Draft Topical Ointment 018726 10/01/2016
Hydrocortisone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone valerate_topical cream_NDA 017950_RC11-17.pdf Draft Topical Cream 017950 02/01/2018
Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060613.pdf Draft Otic Suspension/Drops 060613 05/19/2022
Hydrogen Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209305.pdf Draft Topical Solution 209305 09/01/2019
Hydromorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydromorphone_ER_Tablets_021217_RC07-14.pdf Draft Oral Tablet, Extended Release 021217 07/01/2014
Hydromorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydromorphone HCl_oral tablet_RLD 19892_Final 08-17.pdf Final Oral Tablet 019892 08/01/2017
Hydroxychloroquine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009768.pdf Final Oral Tablet 009768 04/01/2020
Hydroxyprogesterone Caproate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021945.pdf Draft Intramuscular Solution 021945 09/01/2019
Hydroxyurea https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydroxyurea_cap_16295_RC8-08.pdf Draft Oral Capsule 016295 08/01/2008
Hydroxyurea https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208843.pdf Draft Oral Tablet 208843 11/17/2022
Hydroxyzine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydroxyzine_HCl_tabs_88617_88618_88619_RC06-10.pdf Draft Oral Tablet 088617 088618 088619 06/01/2010
Hydroxyzine Pamoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydroxyzine_Pamoate_cap_11459_RC4-09.pdf Final Oral Capsule 011459 10/01/2011
Hydroxyzine Pamoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydroxyzine_Pamoate_susp_11795_RC4-09.pdf Final Oral Suspension 011795 10/01/2011
Ibandronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibandronate_tab_21455_RC11-06.pdf Final Oral Tablet 021455 05/01/2008
Ibrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210563.pdf Draft Oral Tablet 210563 09/01/2019
Ibrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205552.pdf Draft Oral Capsule 205552 03/01/2020
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020601.pdf Draft Oral Tablet, Chewable 020601 08/02/2022
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_Oral Suspension_RLD 074978_RC09-16.pdf Draft Oral Suspension 019842 10/01/2016
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_capsule_020402_RC03-15.pdf Draft Oral Capsule 020402 03/01/2015
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_caps_21472_RC11-10.pdf Draft Oral Capsule 021472 11/01/2010
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_tabs_75682_RC3-10.pdf Draft Oral Tablet 075682 03/01/2010
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_tabs_OTC_19012_RC3-10.pdf Draft Oral Tablet 019012 03/01/2010
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_susp_20516_19842_OTC_RC10-08.pdf Draft Oral Suspension 020516 07/01/2009
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_suspdrp_20603_OTC_RC10-08.pdf Draft Oral Suspension/Drops 020603 10/01/2008
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020812.pdf Draft Oral Suspension/Drops 020812 05/19/2022
Ibuprofen Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen_sodium_tab_201803_RC12-14.pdf Draft Oral Tablet 201803 12/01/2014
Ibuprofen; Phenylephrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen;_Phenlyephrine_HCl_tab_22565_RC10-11.pdf Draft Oral Tablet 022565 10/01/2011
Ibuprofen; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen; Pseudoephrine Hcl_oral capsule_RLD 21374_RC12-16.pdf Draft Oral Capsule 021374 12/01/2016
Ibuprofen; Pseudoephedrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen-Pseudoephedrine HCl susp 21128 RC11-01.pdf Draft Oral Suspension 021128 08/01/2007
Ibuprofen; Pseudoephedrine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ibuprofen-Pseudoephedrine Hydrochloride Oral Tablets NDA 019771 RC 09-2018.pdf Draft Oral Tablet 019771 09/01/2018
Icosapent Ethyl https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202057.pdf Draft Oral Capsule 202057 11/17/2022
Idelalisib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Idelalisib_oral tablet_205858_RC09-15.pdf Draft Oral Tablet 205858 09/01/2015
Iloperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Iloperidone_tab_22192_RC11-10.pdf Draft Oral Tablet 022192 11/01/2010
Imatinib Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imatinib_Mesylate_tab_21588_RV07-14.pdf Draft Oral Tablet 021588 07/01/2014
Imipramine Pamoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imipramine_Pamoate_cap_17090_RC2-11.pdf Draft Oral Capsule 017090 02/01/2011
Imiquimod https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imiquimod Topical Cream 2.5_NDA 022483 RV Feb 2019.pdf Draft Topical Cream 2.5% 022483 02/01/2019
Imiquimod https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imiquimod Topical Cream 3.75_NDA 022483 RV Feb 2019.pdf Draft Topical Cream 3.75% 022483 02/01/2019
Imiquimod https://www.accessdata.fda.gov/drugsatfda_docs/psg/Imiquimod Topical Cream NDA 020723 RV Feb 2019.pdf Draft Topical Cream 020723 02/01/2019
Indacaterol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indacaterol maleate_inhalation powder_RLD 22383_RC04-16.pdf Draft Inhalation Powder 022383 04/01/2016
Indapamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018538.pdf Draft Oral Tablet 018538 11/01/2019
Indinavir Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indinavir_Sulfate_cap_20685_RC4-05.pdf Final Oral Capsule 020685 05/01/2008
Indocyanine Green https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211580.pdf Draft Intravenous, Interstitial Powder 211580 11/01/2019
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indomethacin_oral capsule_204768_RC06-15.pdf Draft Oral Capsule 204768 06/01/2015
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indomethacin_cap_70624_18858_RC2-10.pdf Draft Oral Capsule 016059 02/01/2010
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Indomethacin_ERcap_74464_RC2-10.pdf Draft Oral Capsule, Extended Release 018185 02/01/2010
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017814.pdf Draft Rectal Suppository 017814 08/20/2021
Ingenol Mebutate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ingenol Mebutate Topical Gel 0.05_NDA 202833 RV Feb 2019.pdf Draft Topical Gel 0.050% 202833 02/01/2019
Ingenol Mebutate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ingenol Mebutate Topical Gel 0.015_NDA 202833 RV Feb 2019.pdf Draft Topical Gel 0.015% 202833 02/01/2019
Inotersen Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211172.pdf Draft Subcutaneous Solution 211172 11/17/2022
Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020393.pdf Draft Nasal Spray, Metered 020393 020394 08/20/2021
Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021527.pdf Draft Inhalation Aerosol, Metered 021527 03/24/2021
Irbesartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Irbesartan_tab_20757_RC5-06.pdf Final Oral Tablet 020757 05/01/2008
Irinotecan Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207793.pdf Draft Intravenous Injectable, Liposomal 207793 02/17/2022
Isavuconazonium Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isavuconazonium sulfate_ oral capsule_RLD 207500_RC04-16.pdf Draft Oral Capsule 207500 04/01/2016
Isocarboxazid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isocarboxazid Oral Tablet NDA 011961 RC Feb 2019.pdf Draft Oral Tablet 011961 02/01/2019
Isoniazid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isoniazid_oral tablet_RLD 08678_RC7-08.pdf Draft Oral Tablet 008678 07/01/2008
Isoniazid; Pyrazinamide; Rifampin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050705.pdf Draft Oral Tablet 050705 11/01/2019
Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019790.pdf Draft Oral Capsule, Extended Release 019790 11/01/2019
Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isosorbide Dinitrate_Oral tablet_NDA 012093_RV Nov 2018.pdf Draft Oral Tablet 012093 11/01/2018
Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isosorbide_Dinitrate_tab_087946_RC03-15.pdf Draft Oral Tablet 087946 03/01/2015
Isosorbide Mononitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isosorbide_Mononitrate_ERtab_20225_RC10-05.pdf Final Oral Tablet, Extended Release 020225 05/01/2008
Isotretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021951.pdf Draft Oral Capsule 021951 11/18/2020
Isotretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018662.pdf Draft Oral Capsule 076135 018662 11/18/2020
Isradipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isradipine_cap_77317_RC10-04.pdf Final Oral Capsule 019546 05/01/2008
Isradipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Isradipine_ERtab_20336_RC7-05.pdf Final Oral Tablet, Extended Release 020336 05/01/2008
Istradefylline https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022075.pdf Draft Oral Tablet 022075 03/24/2021
Itraconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Itraconazole_Tab_22484_RC06-12.pdf Draft Oral Tablet 022484 06/01/2012
Itraconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Itraconazole_cap_20083_RC5-06.pdf Draft Oral Capsule 020083<