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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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.
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.
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Total number of currently published PSGs: 2223
206 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/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 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_021478.pdf | Draft | Topical | Cream | 021478 | 10/21/2022 |
| Acyclovir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018604.pdf | Draft | Topical | Ointment | 018604 | 10/21/2022 |
| Acyclovir; 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_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 |
| Air Polymer-Type A | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212279.pdf | Draft | Intrauterine | Foam | 212279 | 08/22/2024 |
| 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/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 | 08/22/2024 |
| Albuterol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf | Draft | Inhalation | Powder, Metered | 205636 | 02/15/2024 |
| 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 | 08/22/2024 |
| 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/Alprazolam_tab_21434_RC6-04.pdf | Draft | Oral | Tablet, Extended Release | 021434 | 11/01/2007 |
| Alprazolam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021726.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021726 | 11/08/2021 |
| 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_019155.pdf | Draft | Topical | Lotion | 019155 | 11/17/2022 |
| Ammonium Lactate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020508.pdf | Draft | Topical | Cream | 020508 | 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_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; 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; 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 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 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_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__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/PSG_210951.pdf | Draft | Oral | Tablet | 210951 | 08/22/2024 |
| 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 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/PSG_213260.pdf | Draft | Oral | Suspension | 213260 | 05/16/2024 |
| 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_206289.pdf | Draft | Ophthalmic | Solution/Drops | 206289 | 02/17/2022 |
| Atropine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213581.pdf | Draft | Ophthalmic | Solution/Drops | 213581 | 08/21/2023 |
| 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/PSG_207071.pdf | Draft | Topical | Aerosol, Foam | 207071 | 11/18/2020 |
| Azelaic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020428.pdf | Draft | Topical | Cream | 020428 | 08/22/2024 |
| 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 |
| 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_ERsusp_50797_RC7-08 .pdf | Draft | Oral | Suspension, Extended Release | 050797 | 07/01/2008 |
| Azithromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Azithromycin_tab_50730_RC1-08.pdf | Draft | Oral | Tablet | 050711 050730 050784 | 01/01/2008 |
| 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 August 22, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Air Polymer-Type A | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212279.pdf | Draft | Intrauterine | Foam | 212279 | 08/22/2024 |
| Fezolinetant | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216578.pdf | Draft | Oral | Tablet | 216578 | 08/22/2024 |
| Heparin Sodium; Taurolidine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214520.pdf | Draft | N/A | Solution | 214520 | 08/22/2024 |
| Leniolisib Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217759.pdf | Draft | Oral | Tablet | 217759 | 08/22/2024 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217722.pdf | Draft | Nasal | Spray, Metered | 217722 | 08/22/2024 |
| Nedosiran Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215842.pdf | Draft | Injection | Solution | 215842 | 08/22/2024 |
| Nirmatrelvir; Ritonavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217188.pdf | Draft | Oral | Tablet; Tablet | 217188 | 08/22/2024 |
| Pegcetacoplan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217171.pdf | Draft | Intravitreal | Solution | 217171 | 08/22/2024 |
| Risperidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212849.pdf | Draft | Intramuscular | For Suspension, Extended Release | 212849 | 08/22/2024 |
| Sotagliflozin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216203.pdf | Draft | Oral | Tablet | 216203 | 08/22/2024 |
| Tafluprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202514.pdf | Draft | Ophthalmic | Solution, Drops | 202514 | 08/22/2024 |
| Teriparatide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021318.pdf | Draft | Subcutaneous | Solution | 021318 | 08/22/2024 |
| Tofersen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215887.pdf | Draft | Intrathecal | Solution | 215887 | 08/22/2024 |
| Trofinetide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217026.pdf | Draft | Oral | Solution | 217026 | 08/22/2024 |
Newly Revised Guidances since August 22, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Albuterol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf | Draft | Inhalation | Aerosol, Metered | 020503 020983 021457 | 08/22/2024 |
| Albuterol Sulfate; Ipratropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf | Draft | Inhalation | Spray, Metered | 021747 | 08/22/2024 |
| Apalutamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210951.pdf | Draft | Oral | Tablet | 210951 | 08/22/2024 |
| Azelaic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020428.pdf | Draft | Topical | Cream | 020428 | 08/22/2024 |
| Bempedoic Acid; Ezetimibe | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211617.pdf | Draft | Oral | Tablet | 211617 | 08/22/2024 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf | Draft | Inhalation | Powder, Metered | 021949 | 08/22/2024 |
| Bupropion Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020358.pdf | Draft | Oral | Tablet, Extended Release | 020358 020711 | 08/22/2024 |
| Carvedilol Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022012.pdf | Draft | Oral | Capsule, Extended Release | 022012 | 08/22/2024 |
| Ciprofloxacin Hydrochloride; Hydrocortisone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020805.pdf | Draft | Otic | Suspension/Drops | 020805 | 08/22/2024 |
| Ciprofloxacin; Dexamethasone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021537.pdf | Draft | Otic | Suspension/Drops | 021537 | 08/22/2024 |
| Cladribine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022561.pdf | Draft | Oral | Tablet | 022561 | 08/22/2024 |
| Dalfampridine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022250.pdf | Draft | Oral | Tablet, Extended Release | 022250 | 08/22/2024 |
| Dapagliflozin; Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205649.pdf | Draft | Oral | Tablet, Extended Release | 205649 | 08/22/2024 |
| Donepezil Hydrochloride; Memantine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206439.pdf | Draft | Oral | Capsule, Extended Release | 206439 | 08/22/2024 |
| Fentanyl Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022569.pdf | Draft | Nasal | Spray, Metered | 022569 | 08/22/2024 |
| Ferric Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf | Draft | Oral | Tablet | 205874 | 08/22/2024 |
| Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf | Draft | Inhalation | Powder | 209482 | 08/22/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021433.pdf | Draft | Inhalation | Aerosol, Metered | 021433 | 08/22/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf | Draft | Inhalation | Powder | 020833 | 08/22/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf | Draft | Inhalation | Powder | 208798 | 08/22/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf | Draft | Inhalation | Powder | 208799 | 08/22/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021254.pdf | Draft | Inhalation | Aerosol, Metered | 021254 | 08/22/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf | Draft | Inhalation | Powder | 021077 | 08/22/2024 |
| Halobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019968.pdf | Draft | Topical | Ointment | 019968 | 08/22/2024 |
| Hydrochlorothiazide; Metoprolol Succinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021956.pdf | Draft | Oral | Tablet, Extended Release | 021956 | 08/22/2024 |
| Hydromorphone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021217.pdf | Draft | Oral | Tablet, Extended Release | 021217 | 08/22/2024 |
| Ibrutinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210563.pdf | Draft | Oral | Tablet | 210563 | 08/22/2024 |
| Levalbuterol Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021730.pdf | Draft | Inhalation | Aerosol, Metered | 021730 | 08/22/2024 |
| Levomilnacipran Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204168.pdf | Draft | Oral | Capsule, Extended Release | 204168 | 08/22/2024 |
| Memantine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022525.pdf | Draft | Oral | Capsule, Extended Release | 022525 | 08/22/2024 |
| Metformin Hydrochloride; Sitagliptin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202270.pdf | Draft | Oral | Tablet, Extended Release | 202270 | 08/22/2024 |
| Metformin Hydrochloride;Saxagliptin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200678.pdf | Draft | Oral | Tablet, Extended Release | 200678 | 08/22/2024 |
| Mometasone Furoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf | Draft | Inhalation | Powder | 021067 | 08/22/2024 |
| Morphine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019516.pdf | Draft | Oral | Tablet, Extended Release | 019516 | 08/22/2024 |
| Morphine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021260.pdf | Draft | Oral | Capsule, Extended Release | 079040 | 08/22/2024 |
| Morphine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020616.pdf | Draft | Oral | Capsule, Extended Release | 020616 | 08/22/2024 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208411.pdf | Draft | Nasal | Spray, Metered | 208411 | 08/22/2024 |
| Olodaterol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf | Draft | Inhalation | Spray, Metered | 203108 | 08/22/2024 |
| Olodaterol Hydrochloride; Tiotropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206756.pdf | Draft | Inhalation | Spray, Metered | 206756 | 08/22/2024 |
| Oxcarbazepine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202810.pdf | Draft | Oral | Tablet, Extended Release | 202810 | 08/22/2024 |
| Oxymorphone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021610.pdf | Draft | Oral | Tablet, Extended Release | 021610 | 08/22/2024 |
| Phentermine Hydrochloride;Topiramate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022580.pdf | Draft | Oral | Capsule, Extended Release | 022580 | 08/22/2024 |
| Posaconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205053.pdf | Draft | Oral | Tablet, Delayed Release | 205053 | 08/22/2024 |
| Pramipexole Dihydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022421.pdf | Draft | Oral | Tablet, Extended Release | 022421 | 08/22/2024 |
| Progesterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022057.pdf | Draft | Vaginal | Insert | 022057 | 08/22/2024 |
| Promethazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010926.pdf | Draft | Rectal | Suppository | 010926 | 08/22/2024 |
| Quetiapine Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022047.pdf | Draft | Oral | Tablet, Extended Release | 022047 | 08/22/2024 |
| Tacrolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206406.pdf | Draft | Oral | Tablet, Extended Release | 206406 | 08/22/2024 |
| Tapentadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200533.pdf | Draft | Oral | Tablet, Extended Release | 200533 | 08/22/2024 |
| Tiotropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021936.pdf | Draft | Inhalation | Spray, Metered | 021936 | 08/22/2024 |
| Tramadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021692.pdf | Draft | Oral | Tablet, Extended Release | 021692 | 08/22/2024 |
| Trospium Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022103.pdf | Draft | Oral | Capsule, Extended Release | 022103 | 08/22/2024 |
| Venlafaxine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022104.pdf | Draft | Oral | Tablet, Extended Release | 022104 | 08/22/2024 |
| Verteporfin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021119.pdf | Draft | Injection | Injectable | 021119 | 08/22/2024 |