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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 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.
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Total number of currently published PSGs: 2136
200 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; 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/Acetaminophen_ERtab_19872_RC2-11.pdf | Draft | Oral | Tablet, Extended Release | 019872 | 02/23/2011 |
| 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 | 08/04/2017 |
| 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_cap_88831_88889_RC3-10.pdf | Draft | Oral | Capsule | 088831 | 03/19/2010 |
| Acetaminophen; Butalbital | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Acetaminophen Butalbital Oral Tablet ANDA 89987 RV Feb 2019.pdf | Draft | Oral | Tablet | 089987 | 02/22/2019 |
| 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 | 11/28/2018 |
| 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_tab_40316__40109_RC4-09.pdf | Final | Oral | Tablet | 040109 | 10/28/2011 |
| 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 | 02/22/2019 |
| 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 | 05/15/2019 |
| 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; Oxycodone HCL_oral ER tablet_RLD 204031_RC 09-16.pdf | Draft | Oral | Tablet, Extended Release | 204031 | 10/04/2016 |
| 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 | 11/28/2018 |
| 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 | 02/25/2010 |
| 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 |
| 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/Aclidinium bromide_inhalation powder_202450_RC09-15.pdf | Draft | Inhalation | Powder, Metered | 202450 | 09/18/2015 |
| 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 | 07/20/2018 |
| 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_018604.pdf | Draft | Topical | Ointment | 018604 | 10/21/2022 |
| 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/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 | 03/28/2012 |
| 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; 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 | 11/21/2019 |
| 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_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/Albendazole_Chewble tablet_RLD 207844_RC04-16.pdf | Draft | Oral | Tablet, Chewable | 207844 | 04/14/2016 |
| Albendazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020666.pdf | Draft | Oral | Tablet | 020666 | 06/03/2020 |
| Albuterol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf | Draft | Inhalation | Aerosol, Metered | 020503 021457 020983 | 03/02/2020 |
| Albuterol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf | Draft | Inhalation | Powder, Metered | 205636 | 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_019604.pdf | Draft | Oral | Tablet, Extended Release | 019604 | 03/02/2020 |
| 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_oral effervescent tablet_202344_RC06-15.pdf | Draft | Oral | Tablet, Effervescent | 202344 | 06/24/2015 |
| 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; 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/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 | 01/27/2016 |
| 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_HCl_tab_76186_RC11-10.pdf | Draft | Oral | Tablet | 018101 | 01/25/2011 |
| 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/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/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_ERtab_50813_RC04-13.pdf | Draft | Oral | Tablet, Extended Release | 050813 | 04/05/2013 |
| Amoxicillin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amoxicillin_cap_061926_RC09-12.pdf | Draft | Oral | Capsule | 050459 | 09/19/2012 |
| Amoxicillin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050542.pdf | Draft | Oral | Tablet, Chewable | 050542 | 06/03/2020 |
| 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; 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 potassiumand 050564_Final 08-17.pdf | Final | Oral | Tablet | 050564 050720 | 08/04/2017 |
| 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/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 | 09/16/2019 |
| Amoxicillin; Omeprazole Magnesium; Rifabutin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213004.pdf | Draft | Oral | Capsule, Delayed Release | 213004 | 08/28/2020 |
| 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 | 11/28/2018 |
| Amphetamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_oral ER suspension_RLD 208147_RC12-16.pdf | Draft | Oral | Suspension, Extended Release | 208147 | 12/22/2016 |
| 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 | 05/16/2017 |
| 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 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 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/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 |
| Aprepitant | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf | Draft | Intravenous | Emulsion | 209296 | 06/03/2020 |
| Aripiprazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021729.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021729 | 11/08/2021 |
| 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/Aripiprazole_ERinjecsusp_202971_RC12-14.pdf | Draft | Intramuscular | For Suspension, Extended Release | 202971 | 12/29/2014 |
| 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 capsule_203697_RC06-15.pdf | Draft | Oral | Capsule | 203697 | 06/24/2015 |
| Aspirin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Aspirin_oral ER capsule_NDA 200671_RC05-17.pdf | Draft | Oral | Capsule, Extended Release | 200671 | 07/13/2017 |
| 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 | 08/04/2017 |
| 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_susp_20500_RC12-09.pdf | Draft | Oral | Suspension | 020500 | 12/17/2009 |
| 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_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_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_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 |
| Azithromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_ERsusp_50797_RC7-08 .pdf | Draft | Oral | Suspension, Extended Release | 050797 | 07/01/2008 |
Newly Added Guidances since August 21, 2023
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Abrocitinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213871.pdf | Draft | Oral | Tablet | 213871 | 08/21/2023 |
| Asciminib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215358.pdf | Draft | Oral | Tablet | 215358 | 08/21/2023 |
| Atogepant | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215206.pdf | Draft | Oral | Tablet | 215206 | 08/21/2023 |
| Atropine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213581.pdf | Draft | Ophthalmic | Solution/Drops | 213581 | 08/21/2023 |
| Avacopan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214487.pdf | Draft | Oral | Capsule | 214487 | 08/21/2023 |
| Chloroprocaine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216227.pdf | Draft | Ophthalmic | Gel | 216227 | 08/21/2023 |
| Daridorexant Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214985.pdf | Draft | Oral | Tablet | 214985 | 08/21/2023 |
| Epinephrine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_201739.pdf | Draft | Intramuscular, Subcutaneous | Solution | 201739 | 08/21/2023 |
| Lidocaine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008816.pdf | Draft | Topical | Jelly | 008816 201094 | 08/21/2023 |
| Lumasiran Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214103.pdf | Draft | Subcutaneous | Solution | 214103 | 08/21/2023 |
| Lutetium Lu-177 Vipivotide Tetraxetan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215833.pdf | Draft | Intravenous | Solution | 215833 | 08/21/2023 |
| Maralixibat Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214662.pdf | Draft | Oral | Solution | 214662 | 08/21/2023 |
| Mavacamten | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214998.pdf | Draft | Oral | Capsule | 214998 | 08/21/2023 |
| Midazolam Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216359.pdf | Draft | Intramuscular | Solution | 216359 | 08/21/2023 |
| Mitapivat Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216196.pdf | Draft | Oral | Tablet | 216196 | 08/21/2023 |
| Mobocertinib Succinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215310.pdf | Draft | Oral | Capsule | 215310 | 08/21/2023 |
| Oteseconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215888.pdf | Draft | Oral | Capsule | 215888 | 08/21/2023 |
| Pacritinib Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208712.pdf | Draft | Oral | Capsule | 208712 | 08/21/2023 |
| Pilocarpine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214028.pdf | Draft | Ophthalmic | Solution | 214028 | 08/21/2023 |
| Ruxolitinib Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215309.pdf | Draft | Topical | Cream | 215309 | 08/21/2023 |
| Tirzepatide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215866.pdf | Draft | Subcutaneous | Solution | 215866 | 08/21/2023 |
| Vutrisiran Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215515.pdf | Draft | Subcutaneous | Solution | 215515 | 08/21/2023 |
Newly Revised Guidances since August 21, 2023
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Beclomethasone Dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020911.pdf | Draft | Inhalation | Aerosol, Metered | 020911 | 08/21/2023 |
| Beclomethasone Dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207921.pdf | Draft | Inhalation | Aerosol, Metered | 207921 | 08/21/2023 |
| Beclomethasone Dipropionate Monohydrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019389.pdf | Draft | Nasal | Spray, Metered | 019389 | 08/21/2023 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020746.pdf | Draft | Nasal | Spray, Metered | 020746 | 08/21/2023 |
| Ciclesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021658.pdf | Draft | Inhalation | Aerosol, Metered | 021658 | 08/21/2023 |
| Ciclesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022004.pdf | Draft | Nasal | Spray, Metered | 022004 | 08/21/2023 |
| Clascoterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213433.pdf | Draft | Topical | Cream | 213433 | 08/21/2023 |
| Diclofenac Epolamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021234.pdf | Draft | Topical | System | 021234 | 08/21/2023 |
| Epinephrine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205920.pdf | Draft | Inhalation | Aerosol, Metered | 205920 | 08/21/2023 |
| Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021258.pdf | Draft | Transdermal | Film, Extended Release | 021258 | 08/21/2023 |
| Fluvoxamine Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022033.pdf | Draft | Oral | Capsule, Extended Release | 022033 | 08/21/2023 |
| Glucagon | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212097.pdf | Draft | Subcutaneous | Solution | 212097 | 08/21/2023 |
| Ipratropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021527.pdf | Draft | Inhalation | Aerosol, Metered | 021527 | 08/21/2023 |
| Mometasone Furoate; Olopatadine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211746.pdf | Draft | Nasal | Spray, Metered | 211746 | 08/21/2023 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020468.pdf | Draft | Nasal | Spray, Metered | 020468 | 08/21/2023 |
| Voxelotor | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213137.pdf | Draft | Oral | Tablet | 213137 | 08/21/2023 |