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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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 facilitate generic drug product availability and further assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, the FDA publishes product-specific guidances (PSG). PSGs describe the Agency's current thinking and expectations to develop generic drug products therapeutically equivalent to specific RLDs.

The FDA publishes PSGs to foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs.

PSGs 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.

The implementation of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 20221 (GDUFA III). with regard to issuance of PSGs is effective on October 1, 2022. Under GDUFA III, the 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 two years after the date of approval, and for 75 percent of such NDA products within three 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 two years after the date of approval for 90 percent of such products.
In addition to GDUFA III PSG goals, the FDA considers several factors when prioritizing PSG development. The FDA evaluates the generic industries and other stakeholders' interest in products that do not have a PSG through controlled correspondences, public requests, and pre-ANDA meeting requests.

The FDA also evaluates drug availability and accessibility and considers public health priorities, including but not limited to, public health emergencies and drug safety and efficacy updates. In addition to these elements, the FDA continually assesses the status and outcomes of ongoing GDUFA research to ensure there are sufficient and adequate data and evidence to support the development of PSGs that align with the FDA's current scientific thinking.

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.

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: 2187

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

205 record(s) found for 'A'

Active Ingredient (link to Specific Guidance) URL 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 08/28/2020
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215413.pdf Draft Oral Tablet, For Suspension 215413 02/15/2024
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 09/13/2018
Abiraterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Abiraterone acetate_oral tablet_NDA 202379_RV07-18.pdf Draft Oral Tablet 202379 07/20/2018
Abiraterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210308.pdf Draft Oral Tablet 210308 06/03/2020
Abrocitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213871.pdf Draft Oral Tablet 213871 08/21/2023
Acalabrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acalabrutinib Oral Capsules NDA 210259 RC Feb 2019.pdf Draft Oral Capsule 210259 02/22/2019
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 05/16/2017
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/PSG_018337.pdf Draft Rectal Suppository 018337 05/19/2022
Acetaminophen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen_ERtab_19872_RC2-11.pdf Draft Oral Tablet, Extended Release 019872 02/23/2011
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 08/04/2017
Acetaminophen; Benzhydrocodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208653.pdf Draft Oral Tablet 208653 11/21/2019
Acetaminophen; Butalbital https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen Butalbital Oral Tablet ANDA 89987 RV Feb 2019.pdf Draft Oral Tablet 089987 02/22/2019
Acetaminophen; Butalbital https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen;_Butalbital_cap_88831_88889_RC3-10.pdf Draft Oral Capsule 088831 03/19/2010
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 11/28/2018
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 11/28/2018
Acetaminophen; Butalbital; Caffeine; Codeine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen ; ButalbitalRLD_020232_Final 08-17.pdf Final Oral Capsule 020232 08/04/2017
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 02/22/2019
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 10/28/2011
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 05/15/2019
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 06/16/2016
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;OxycodoneHCL_Oral tablet_ANDA 40330_RV Oct 2018.pdf Draft Oral Tablet 040330 11/28/2018
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 10/04/2016
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 Oral Tablet NDA 008943 RV 09-2018.pdf Draft Oral Tablet 008943 09/13/2018
Acetazolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetazolamide_ERcaps_12945_RC2-10.pdf Draft Oral Capsule, Extended Release 012945 02/25/2010
Acetylcysteine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetylcystein_oral effervescent tablet_RLD 207916_RC03-17.pdf Draft Oral Tablet, Effervescent 207916 05/16/2017
Acitretin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acitretin_Oral Capsule_RLD19821_Final 08-17.pdf Final Oral Capsule 019821 08/04/2017
Aclidinium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202450.pdf Draft Inhalation Powder, Metered 202450 02/15/2024
Aclidinium Bromide; Formoterol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210595.pdf Draft Inhalation Powder, Metered 210595 02/15/2024
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 07/20/2018
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acyclovir_cap_18828_RC03-12.pdf Draft Oral Capsule 018828 03/28/2012
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019909.pdf Draft Oral Suspension 019909 09/16/2019
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/PSG_202408.pdf Draft Ophthalmic Ointment 202408 08/20/2021
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_018604.pdf Draft Topical Ointment 018604 10/21/2022
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021478.pdf Draft Topical Cream 021478 10/21/2022
Acyclovir; Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022436.pdf Draft Topical Cream 022436 10/21/2022
Adagrasib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216340.pdf Draft Oral Tablet 216340 02/15/2024
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020748.pdf Draft Topical Cream 020748 11/21/2019
Adapalene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022502.pdf Draft Topical Lotion 022502 11/21/2019
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
Afamelanotide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210797.pdf Draft Subcutaneous Implant 210797 02/16/2023
Afatinib Dimaleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Afatinib dimaleate_Oral tablet_201292_RC06-15.pdf Draft Oral Tablet 201292 06/24/2015
Albendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020666.pdf Draft Oral Tablet 020666 06/03/2020
Albendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Albendazole_Chewble tablet_RLD 207844_RC04-16.pdf Draft Oral Tablet, Chewable 207844 04/14/2016
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019604.pdf Draft Oral Tablet, Extended Release 019604 03/02/2020
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Albuterol sulfate_oral tablet_RLD 072894_RV06-16.pdf Draft Oral Tablet 017853 06/16/2016
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf Draft Inhalation Aerosol, Metered 020503 020983 021457 11/16/2023
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf Draft Inhalation Powder, Metered 205636 02/15/2024
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 02/08/2018
Alectinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alectinib HCl_oral capsule_RLD 208434_RC09-16.pdf Draft Oral Capsule 208434 10/04/2016
Alendronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alendronate__Sodium_tab_20560_RC1-08.pdf Draft Oral Tablet 020560 10/27/2011
Alendronate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alendronate sodium_oral effervescent tablet_202344_RC06-15.pdf Draft Oral Tablet, Effervescent 202344 06/24/2015
Alendronate Sodium; Cholecalciferol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alendronate_Cholecalciferol_tab_21762_RC4-09.pdf Draft Oral Tablet 021762 10/27/2011
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 08/18/2009
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 06/14/2012
Aliskiren Hemifumarate; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren;_HCTZ_tab_22107_RC8-09.pdf Draft Oral Tablet 022107 08/18/2009
Aliskiren Hemifumarate; Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aliskiren_Hemifumarate;_Valsartan_tab_22217_RC03-11.pdf Draft Oral Tablet 022217 03/31/2011
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 09/13/2018
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 07/22/2014
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 07/22/2014
Alogliptin Benzoate; Pioglitazone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alogliptin_benzoate_Pioglitazone_tab_22426_RC07-14.pdf Draft Oral Tablet 022426 07/22/2014
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 08/28/2020
Alprazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alprazolam_tab_18276_RC3-05.pdf Draft Oral Tablet 018276 09/01/2008
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
Alprostadil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alprostadil_urethral suppository_RLD 020700_RC01-16.pdf Draft Urethral Suppository 020700 01/27/2016
Altretamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Altretamine_caps_19926_RC04-10.pdf Draft Oral Capsule 019926 04/20/2010
Alvimopan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Alvimopan_Cap_21775_RC06-12 .pdf Draft Oral Capsule 021775 06/14/2012
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amamtadine Hydrochloride_Oral Capsule_ 071293_RV09-15.pdf Draft Oral Capsule 016020 09/18/2015
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 09/13/2018
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amantadine_HCl_tab_76186_RC11-10.pdf Draft Oral Tablet 018101 01/25/2011
Amantadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209410.pdf Draft Oral Tablet, Extended Release 209410 09/16/2019
Ambrisentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ambrisentan_tab_22081_RV06-13.pdf Draft Oral Tablet 022081 06/19/2013
Amcinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amcinonide_topical lotion_RLD 76329_RC 06-16.pdf Draft Topical Lotion 076329 06/16/2016
Amifampridine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208078.pdf Draft Oral Tablet 208078 03/02/2020
Amiloride Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amiloride_tab_ 70346_RC03-12.pdf Draft Oral Tablet 018200 03/28/2012
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 03/02/2020
Aminocaproic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aminocaproic acid_oral tablet_015197_RC09-15.pdf Draft Oral Tablet 015197 09/18/2015
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 12/23/2010
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 02/08/2018
Amlodipine Benzoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211340.pdf Draft Oral Suspension 211340 08/28/2020
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 05/19/2021
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 12/14/2012
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 04/14/2016
Amlodipine Besylate; Telmisartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amlodipine_Besylate;_Telmisartan_tabs_ 22401_RC08-10.pdf Draft Oral Tablet 022401 08/30/2010
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 04/20/2010
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 06/03/2020
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_ERtab_50813_RC04-13.pdf Draft Oral Tablet, Extended Release 050813 04/05/2013
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Oral Suspension_RLD 50460_final 08-17.pdf Final Oral Suspension 050460 08/04/2017
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Oral Suspension_RLD 065119_Final 08-17.pdf Final Oral Suspension 065119 08/04/2017
Amoxicillin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_cap_061926_RC09-12.pdf Draft Oral Capsule 050459 09/19/2012
Amoxicillin; Clarithromycin; Omeprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050824.pdf Draft Oral Capsule, Tablet, Capsule, Delayed Release 050824 08/28/2020
Amoxicillin; Clarithromycin; Vonoprazan Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215152.pdf Draft Oral Capsule, Tablet, Tablet 215152 02/15/2024
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Clavu_chew_50597_RC1-08.pdf Draft Oral Tablet, Chewable 050597 02/23/2008
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/PSG_050785.pdf Draft Oral Tablet, Extended Release 050785 09/16/2019
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_Clavulanate_potassium_susp_50575_RC09-12.pdf Draft Oral Suspension 050575 09/19/2012
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/Amoxicillin; Clavulanate potassiumand 050564_Final 08-17.pdf Final Oral Tablet 050564 050720 08/04/2017
Amoxicillin; Omeprazole Magnesium; Rifabutin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213004.pdf Draft Oral Capsule, Delayed Release 213004 08/28/2020
Amoxicillin; Vonoprazan Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215153.pdf Draft Oral Capsule, Tablet 215153 02/15/2024
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 05/16/2017
Amphetamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_oral ER suspension_RLD 208147_RC12-16.pdf Draft Oral Suspension, Extended Release 208147 12/22/2016
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 11/28/2018
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 09/19/2012
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 09/13/2018
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 11/05/2013
Amphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine sulfate_oral tablet_ANDA 200166_RC11-17.pdf Draft Oral Tablet 200166 02/08/2018
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 08/28/2020
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 02/22/2019
Apalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Apalutamide Oral Tablets NDA 210951 PSG Page RC May 2019.pdf Draft Oral Tablet 210951 05/15/2019
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 09/18/2015
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf Draft Intravenous Emulsion 209296 216457 02/15/2024
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 05/16/2017
Aripiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aripiprazole_ERinjecsusp_202971_RC12-14.pdf Draft Intramuscular For Suspension, Extended Release 202971 12/29/2014
Aripiprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aripiprazole Oral Tablet NDA 021436 RV Feb 2019.pdf Draft Oral Tablet 021436 02/22/2019
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 09/16/2019
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 06/19/2013
Artesunate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213036.pdf Draft Intravenous Powder 213036 11/08/2021
Asciminib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215358.pdf Draft Oral Tablet 215358 08/21/2023
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 11/28/2018
Aspirin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin_oral ER capsule_NDA 200671_RC05-17.pdf Draft Oral Capsule, Extended Release 200671 07/13/2017
Aspirin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin_oral capsule_203697_RC06-15.pdf Draft Oral Capsule 203697 06/24/2015
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 08/04/2017
Aspirin; Butalbital; Caffeine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin;_Butalbital;_Caffeine_tab_86162_RC3-10.pdf Final Oral Tablet 017534 08/04/2017
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 08/04/2017
Aspirin; Dipyridamole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin;_Dipyridamole_ERcap_20884_RC3-10.pdf Draft Oral Capsule, Extended Release 020884 03/19/2010
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 02/08/2018
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 02/25/2010
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 01/27/2016
Atenolol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atenolol_oral tablet_ RLD 18240_Final 08-17.pdf Final Oral Tablet 018240 08/04/2017
Atenolol; Chlorthalidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atenolol; Chlorthalidone_oral tablet_ RLD 18760_Final 08-17.pdf Final Oral Tablet 018760 08/04/2017
Atogepant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215206.pdf Draft Oral Tablet 215206 08/21/2023
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 10/22/2010
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_tab_20259_RC5-05.pdf Draft Oral Tablet 020259 11/01/2007
Atovaquone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Atovaquone_susp_20500_RC12-09.pdf Draft Oral Suspension 020500 12/17/2009
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_213581.pdf Draft Ophthalmic Solution/Drops 213581 08/21/2023
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 11/28/2018
Auranofin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Auranofin_cap_18689_RC2-10.pdf Draft Oral Capsule 018689 02/25/2010
Avacopan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214487.pdf Draft Oral Capsule 214487 08/21/2023
Avanafil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Avanafil_oral tab_202276_RC03-15.pdf Draft Oral Tablet 202276 03/06/2015
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 09/16/2019
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_214120.pdf Draft Oral Tablet 214120 11/16/2023
Azacitidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050794.pdf Draft Intravenous, Subcutaneous Powder 050794 05/19/2021
Azathioprine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azathioprine_tabs_16324_RC09-10.pdf Draft Oral Tablet 016324 09/30/2010
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 05/15/2019
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 05/15/2019
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/PSG_213872.pdf Draft Nasal Spray, Metered 213872 08/02/2022
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 10/19/2017
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020114.pdf Draft Nasal Spray, Metered 020114 08/02/2022
Azelastine Hydrochloride; Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202236.pdf Draft Nasal Spray, Metered 202236 05/18/2023
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 03/06/2015
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_tab_50730_RC1-08.pdf Draft Oral Tablet 050711 050730 050784 01/01/2008
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_oral for suspension_NDA 050693_RC08-17.pdf Draft Oral For Suspension 050693 10/19/2017
Azithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_susp_50693_50710_RC12-08.pdf Draft Oral For Suspension 050710 12/20/2008

Newly Added Guidances since February 15, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Abacavir Sulfate; Dolutegravir Sodium; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215413.pdf Draft Oral Tablet, For Suspension 215413 02/15/2024
Adagrasib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216340.pdf Draft Oral Tablet 216340 02/15/2024
Amoxicillin; Clarithromycin; Vonoprazan Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215152.pdf Draft Oral Capsule, Tablet, Tablet 215152 02/15/2024
Amoxicillin; Vonoprazan Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215153.pdf Draft Oral Capsule, Tablet 215153 02/15/2024
Baclofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215422.pdf Draft Oral Granules 215422 02/15/2024
Budesonide; Formoterol Fumarate; Glycopyrrolate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212122.pdf Draft Inhalation Aerosol, Metered 212122 02/15/2024
Caffeine; Ergotamine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_086557.pdf Draft Rectal Suppository 086557 009000 02/15/2024
Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216974.pdf Draft Intravenous Powder 216974 02/15/2024
Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213388.pdf Draft Oral Capsule 213388 02/15/2024
Ferric Derisomaltose https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208171.pdf Draft Intravenous Solution 208171 02/15/2024
Finasteride; Tadalafil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215423.pdf Draft Oral Capsule 215423 02/15/2024
Flotufolastat F-18 Gallium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216023.pdf Draft Intravenous Solution 216023 02/15/2024
Formoterol Fumarate; Glycopyrrolate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208294.pdf Draft Inhalation Aerosol, Metered 208294 02/15/2024
Lenacapavir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215974.pdf Draft Oral Tablet 215974 02/15/2024
Lenacapavir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215973.pdf Draft Subcutaneous Solution 215973 02/15/2024
Mannitol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022368.pdf Draft Inhalation Powder 022368 02/15/2024
Mannitol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202049.pdf Draft Inhalation Powder 202049 02/15/2024
Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208969.pdf Draft Nasal Spray, Metered 208969 02/15/2024
Niraparib Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214876.pdf Draft Oral Tablet 214876 02/15/2024
Olutasidenib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215814.pdf Draft Oral Capsule 215814 02/15/2024
Oxymetazoline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212520.pdf Draft Ophthalmic Solution/Drops 212520 04/02/2024
Rivaroxaban https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215859.pdf Draft Oral For Suspension 215859 02/15/2024
Sertraline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215133.pdf Draft Oral Capsule 215133 02/15/2024
Sodium Phenylbutyrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214860.pdf Draft Oral For Suspension 214860 02/15/2024
Sodium Phenylbutyrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216513.pdf Draft Oral Pellets 216513 02/15/2024
Sodium Phenylbutyrate; Taurursodiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216660.pdf Draft Oral For Suspension 216660 02/15/2024
Terlipressin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022231.pdf Draft Intravenous Powder 022231 02/15/2024
Testosterone Undecanoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213953.pdf Draft Oral Capsule 213953 02/15/2024
Xenon Xe-129 Hyperpolarized https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214375.pdf Draft Inhalation Gas 214375 02/15/2024
Zanamivir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021036.pdf Draft Inhalation Powder 021036 02/15/2024

Newly Revised Guidances since February 15, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Aclidinium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202450.pdf Draft Inhalation Powder, Metered 202450 02/15/2024
Aclidinium Bromide; Formoterol Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210595.pdf Draft Inhalation Powder, Metered 210595 02/15/2024
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf Draft Inhalation Powder, Metered 205636 02/15/2024
Aprepitant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf Draft Intravenous Emulsion 209296 216457 02/15/2024
Betamethasone Dipropionate; Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020010.pdf Draft Topical Lotion 020010 076493 02/15/2024
Betamethasone Dipropionate; Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018827.pdf Draft Topical Cream 018827 075673 02/15/2024
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf Draft Inhalation Powder, Metered 021949 02/15/2024
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207154.pdf Draft Topical Gel 207154 02/15/2024
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021794.pdf Draft Topical Gel 021794 02/15/2024
Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050023.pdf Draft Ophthalmic Suspension/Drops 050023 02/15/2024
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050616.pdf Draft Ophthalmic Ointment 050616 02/15/2024
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050592.pdf Draft Ophthalmic Suspension/Drops 050592 02/15/2024
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050818.pdf Draft Ophthalmic Suspension/Drops 050818 02/15/2024
Diazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211635.pdf Draft Nasal Spray 211635 02/15/2024
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022036.pdf Draft Oral Tablet 022036 02/15/2024
Ferric Carboxymaltose https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203565.pdf Draft Intravenous Solution 203565 02/15/2024
Fluorometholone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016851.pdf Draft Ophthalmic Suspension/Drops 016851 02/15/2024
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf Draft Inhalation Powder 209482 02/15/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf Draft Inhalation Powder 208798 02/15/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf Draft Inhalation Powder 020833 02/15/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf Draft Inhalation Powder 021077 02/15/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf Draft Inhalation Powder 208799 02/15/2024
Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060613.pdf Draft Otic Suspension/Drops 060613 02/15/2024
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf Draft Ophthalmic Suspension/Drops 020583 02/15/2024
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200738.pdf Draft Ophthalmic Ointment 200738 02/15/2024
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020803.pdf Draft Ophthalmic Suspension/Drops 020803 02/15/2024
Loteprednol Etabonate; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050804.pdf Draft Ophthalmic Suspension/Drops 050804 02/15/2024
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf Draft Inhalation Powder 021067 02/15/2024
Nilotinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022068.pdf Draft Oral Capsule 022068 02/15/2024
Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020692.pdf Draft Inhalation Powder 020692 02/15/2024
Umeclidinium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205382.pdf Draft Inhalation Powder 205382 02/15/2024
Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203975.pdf Draft Inhalation Powder 203975 02/15/2024
Vandetanib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022405.pdf Draft Oral Tablet 022405 02/15/2024
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