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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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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2
Total number of currently published PSGs: 2407
224 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/PSG_020977.pdf | Draft | Oral | Tablet | 020977 | 10/30/2024 |
| Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205551.pdf | Draft | Oral | Tablet | 205551 | 10/30/2024 |
| Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215413.pdf | Draft | Oral | Tablet, For Suspension | 215413 | 10/30/2024 |
| Abacavir Sulfate; Lamivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021652.pdf | Draft | Oral | Tablet | 021652 | 10/30/2024 |
| Abacavir Sulfate; Lamivudine; Zidovudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021205.pdf | Draft | Oral | Tablet | 021205 | 10/30/2024 |
| 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/PSG_208716.pdf | Draft | Oral | Tablet | 208716 | 10/30/2024 |
| Abiraterone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202379.pdf | Draft | Oral | Tablet | 202379 | 10/01/2025 |
| Abiraterone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210308.pdf | Draft | Oral | Tablet | 210308 | 06/03/2020 |
| Abiraterone Acetate; Niraparib Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216793.pdf | Draft | Oral | Tablet | 216793 | 10/01/2025 |
| Abrocitinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213871.pdf | Draft | Oral | Tablet | 213871 | 10/30/2024 |
| Acalabrutinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210259.pdf | Draft | Oral | Capsule | 210259 | 10/30/2024 |
| Acalabrutinib Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216387.pdf | Draft | Oral | Tablet | 216387 | 11/19/2024 |
| 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 |
| Aceclidine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218585.pdf | Draft | Ophthalmic | Solution/Drops | 218585 | 02/26/2026 |
| 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 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206968.pdf | Draft | Intravenous | Solution | 206968 | 02/26/2026 |
| Acetaminophen; Aspirin; Caffeine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020802.pdf | Draft | Oral | Tablet | 020802 | 10/30/2024 |
| Acetaminophen; Benzhydrocodone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208653.pdf | Draft | Oral | Tablet | 208653 | 10/30/2024 |
| 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/PSG_088831.pdf | Draft | Oral | Capsule | 088831 207313 | 10/01/2025 |
| 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/PSG_020232.pdf | Draft | Oral | Capsule | 020232 | 10/30/2024 |
| 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 | 02/26/2026 |
| 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/PSG_017122.pdf | Draft | Oral | Tablet | 076429 | 10/30/2024 |
| Acetaminophen; Tramadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021123.pdf | Draft | Oral | Tablet | 021123 | 10/30/2024 |
| Acetazolamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008943.pdf | Draft | Oral | Tablet | 008943 | 10/30/2024 |
| 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/PSG_207916.pdf | Draft | Oral | Tablet, Effervescent | 207916 | 10/30/2024 |
| 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 | 11/06/2025 |
| Aclidinium Bromide; Formoterol Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210595.pdf | Draft | Inhalation | Powder, Metered | 210595 | 11/06/2025 |
| Acoltremon | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217370.pdf | Draft | Ophthalmic | Solution/Drops | 217370 | 02/26/2026 |
| Acoramidis Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216540.pdf | Draft | Oral | Tablet | 216540 | 12/04/2025 |
| Acrivastine; Pseudoephedrine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019806.pdf | Draft | Oral | Capsule | 019806 | 10/30/2024 |
| Acyclovir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018828.pdf | Draft | Oral | Capsule | 018828 | 10/30/2024 |
| 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_021478.pdf | Draft | Topical | Cream | 021478 | 10/21/2022 |
| Acyclovir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019909.pdf | Draft | Oral | Suspension | 019909 | 10/30/2024 |
| 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_020089.pdf | Draft | Oral | Tablet | 020089 | 10/30/2024 |
| 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 | 10/30/2024 |
| Adapalene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020748.pdf | Draft | Topical | Cream | 020748 | 11/21/2019 |
| Adapalene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_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 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022502.pdf | Draft | Topical | Lotion | 022502 | 11/21/2019 |
| 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 |
| Adapalene; Benzoyl Peroxide; Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216632.pdf | Draft | Topical | Gel | 216632 | 11/19/2024 |
| Adefovir Dipivoxil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021449.pdf | Draft | Oral | Tablet | 021449 | 10/30/2024 |
| 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/PSG_205636.pdf | Draft | Inhalation | Powder, Metered | 205636 | 10/01/2025 |
| 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_017853.pdf | Draft | Oral | Tablet | 017853 | 10/30/2024 |
| Albuterol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019604.pdf | Draft | Oral | Tablet, Extended Release | 019604 | 03/02/2020 |
| Albuterol Sulfate; Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214070.pdf | Draft | Inhalation | Aerosol, Metered | 214070 | 05/20/2025 |
| 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/PSG_208434.pdf | Draft | Oral | Capsule | 208434 | 10/01/2025 |
| 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/PSG_016084.pdf | Draft | Oral | Tablet | 016084 | 11/19/2024 |
| Allopurinol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016084-Sus.pdf | Draft | Oral | Suspension | 016084 | 11/19/2024 |
| Allopurinol; Lesinurad | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209203.pdf | Draft | Oral | Tablet | 209203 | 10/30/2024 |
| Almotriptan Malate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021001.pdf | Draft | Oral | Tablet | 021001 | 10/30/2024 |
| Alogliptin Benzoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022271.pdf | Draft | Oral | Tablet | 022271 | 10/30/2024 |
| Alogliptin Benzoate; Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203414.pdf | Draft | Oral | Tablet | 203414 | 10/30/2024 |
| Alogliptin Benzoate; Pioglitazone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022426.pdf | Draft | Oral | Tablet | 022426 | 10/30/2024 |
| Alosetron Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021107.pdf | Draft | Oral | Tablet | 021107 | 10/30/2024 |
| Alpelisib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215039.pdf | Draft | Oral | Tablet | 215039 | 02/26/2026 |
| Alpelisib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212526.pdf | Draft | Oral | Tablet | 212526 | 02/26/2026 |
| Alpelisib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218466.pdf | Draft | Oral | Granule | 218466 | 02/26/2026 |
| Alprazolam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021726.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021726 | 10/30/2024 |
| 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_018276.pdf | Draft | Oral | Tablet | 018276 | 10/30/2024 |
| 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/PSG_016020.pdf | Draft | Oral | Capsule | 016020 | 10/30/2024 |
| Amantadine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208944.pdf | Draft | Oral | Capsule, Extended Release | 208944 | 10/01/2025 |
| Amantadine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209410.pdf | Draft | Oral | Tablet, Extended Release | 209410 | 09/16/2019 |
| Amantadine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018101.pdf | Draft | Oral | Tablet | 018101 | 10/30/2024 |
| Ambrisentan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022081.pdf | Draft | Oral | Tablet | 022081 | 11/06/2025 |
| 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 | 10/01/2025 |
| Amiloride Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018200.pdf | Draft | Oral | Tablet | 018200 | 10/30/2024 |
| Amino Acids; Calcium Chloride; Dextrose; Magnesium Sulfate; Potassium Chloride; Sodium Acetate; Sodium Glycerophosphate; Soyb | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200656.pdf | Draft | Intravenous | Emulsion | 200656 | 11/06/2025 |
| Aminocaproic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_015197.pdf | Draft | Oral | Tablet | 015197 | 10/30/2024 |
| 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/PSG_018972.pdf | Draft | Oral | Tablet | 018972 | 10/30/2024 |
| 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/PSG_012703.pdf | Draft | Oral | Tablet | 085966 085967 085968 085969 085970 085971 012703 | 10/30/2024 |
| Amitriptyline Hydrochloride; Chlordiazepoxide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016949.pdf | Draft | Oral | Tablet | 016949 | 10/30/2024 |
| Amlodipine Benzoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211340.pdf | Draft | Oral | Suspension | 211340 | 10/30/2024 |
| Amlodipine Besylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019787.pdf | Draft | Oral | Tablet | 019787 | 10/30/2024 |
| Amlodipine Besylate; Atorvastatin Calcium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021540.pdf | Draft | Oral | Tablet | 021540 | 10/30/2024 |
| Amlodipine Besylate; Benazepril Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020364.pdf | Draft | Oral | Capsule | 020364 | 10/30/2024 |
| Amlodipine Besylate; Celecoxib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210045.pdf | Draft | Oral | Tablet | 210045 | 10/30/2024 |
| Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200175.pdf | Draft | Oral | Tablet | 200175 | 10/30/2024 |
| Amlodipine Besylate; Hydrochlorothiazide; Valsartan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022314.pdf | Draft | Oral | Tablet | 022314 | 10/30/2024 |
| Amlodipine Besylate; Olmesartan Medoxomil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022100.pdf | Draft | Oral | Tablet | 022100 | 10/30/2024 |
| Amlodipine Besylate; Perindopril Arginine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205003.pdf | Draft | Oral | Tablet | 205003 | 10/30/2024 |
| Amlodipine Besylate; Telmisartan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022401.pdf | Draft | Oral | Tablet | 022401 | 08/30/2010 |
| Amlodipine Besylate; Valsartan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021990.pdf | Draft | Oral | Tablet | 021990 | 10/30/2024 |
| 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_050459.pdf | Draft | Oral | Capsule | 050459 | 10/30/2024 |
| Amoxicillin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050542.pdf | Draft | Oral | Tablet, Chewable | 050542 | 10/30/2024 |
| 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/PSG_050460.pdf | Draft | Oral | For Suspension | 050460 | 10/30/2024 |
| Amoxicillin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050760.pdf | Draft | Oral | For Suspension | 065119 050760 | 10/30/2024 |
| 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 | 10/30/2024 |
| Amoxicillin; Clavulanate Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050725.pdf | Draft | Oral | For Suspension | 050725 050755 | 10/30/2024 |
| Amoxicillin; Clavulanate Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050575.pdf | Draft | Oral | For Suspension | 050575 | 10/30/2024 |
| Amoxicillin; Clavulanate Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050785.pdf | Draft | Oral | Tablet, Extended Release | 050785 | 09/16/2019 |
| Amoxicillin; Clavulanate Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050597.pdf | Draft | Oral | Tablet, Chewable | 050597 | 10/30/2024 |
| Amoxicillin; Clavulanate Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050726.pdf | Draft | Oral | Tablet, Chewable | 050726 | 10/30/2024 |
| Amoxicillin; Clavulanate Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050564.pdf | Draft | Oral | Tablet | 050564 050720 | 10/30/2024 |
| Amoxicillin; Omeprazole Magnesium; Rifabutin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213004.pdf | Draft | Oral | Capsule, Delayed Release | 213004 | 02/26/2026 |
| Amoxicillin; Vonoprazan Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215153.pdf | Draft | Oral | Capsule; Tablet | 215153 | 10/30/2024 |
| Amphetamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204326.pdf | Draft | Oral | Tablet, Orally Disintegrating, Extended Release | 204326 | 11/06/2025 |
| Amphetamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_oral ER suspension_RLD 208147_RC12-16.pdf | Draft | Oral | Suspension, Extended Release | 208147 | 12/22/2016 |
| Amphetamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Amphetamine_Oral suspension_NDA 204325_PSG Page RC Nov 2018.pdf | Draft | Oral | Suspension, Extended Release | 204325 | 11/28/2018 |
| Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011522.pdf | Draft | Oral | Tablet | 011522 | 10/30/2024 |
| 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/PSG_020333.pdf | Draft | Oral | Capsule | 020333 | 10/30/2024 |
| Anastrozole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020541.pdf | Draft | Oral | Tablet | 020541 | 10/30/2024 |
| 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_220073.pdf | Draft | Oral | For Suspension | 220073 | 02/26/2026 |
| Apixaban | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202155.pdf | Draft | Oral | Tablet | 202155 | 02/26/2026 |
| Apomorphine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214056.pdf | Draft | Subcutaneous | Solution | 214056 | 12/04/2025 |
| 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/PSG_205437.pdf | Draft | Oral | Tablet | 205437 | 10/30/2024 |
| 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 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 |
| Aprocitentan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217686.PDF | Draft | Oral | Tablet | 217686 | 11/06/2025 |
| Arimoclomol Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214927.pdf | Draft | Oral | Capsule | 214927 | 12/04/2025 |
| Aripiprazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217006.pdf | Draft | Intramuscular | Suspension, Extended Release | 217006 | 11/19/2024 |
| Aripiprazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021436.pdf | Draft | Oral | Tablet | 021436 | 10/30/2024 |
| Aripiprazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021729.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021729 | 10/30/2024 |
| Aripiprazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202971.pdf | Draft | Intramuscular | For Suspension, Extended Release | 202971 | 05/20/2025 |
| Aripiprazole Lauroxil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209830.pdf | Draft | Intramuscular | Suspension, Extended Release | 209830 | 11/19/2024 |
| Armodafinil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021875.pdf | Draft | Oral | Tablet | 021875 | 10/30/2024 |
| 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 | 11/06/2025 |
| Asenapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212268.pdf | Draft | Transdermal | System | 212268 | 02/26/2026 |
| 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/PSG_200671.pdf | Draft | Oral | Capsule, Extended Release | 200671 | 10/01/2025 |
| Aspirin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203697.pdf | Draft | Oral | Capsule | 203697 | 10/30/2024 |
| 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/PSG_019429.pdf | Draft | Oral | Capsule | 019429 | 10/30/2024 |
| 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/PSG_021567.pdf | Draft | Oral | Capsule | 021567 | 10/30/2024 |
| Atazanavir Sulfate; Cobicistat | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206353.pdf | Draft | Oral | Tablet | 206353 | 10/30/2024 |
| Atenolol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018240.pdf | Draft | Oral | Tablet | 018240 | 10/30/2024 |
| Atenolol; Chlorthalidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018760.pdf | Draft | Oral | Tablet | 018760 | 10/30/2024 |
| 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/PSG_021411.pdf | Draft | Oral | Capsule | 021411 | 10/30/2024 |
| Atorvastatin Calcium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020702.pdf | Draft | Oral | Tablet | 020702 | 10/30/2024 |
| Atorvastatin Calcium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213260.pdf | Draft | Oral | Suspension | 213260 | 10/30/2024 |
| Atorvastatin Calcium; Ezetimibe | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200153.pdf | Draft | Oral | Tablet | 200153 206084 | 10/30/2024 |
| Atovaquone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020259.pdf | Draft | Oral | Tablet | 020259 | 10/30/2024 |
| Atovaquone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020500.pdf | Draft | Oral | Suspension | 020500 | 10/30/2024 |
| 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/PSG_018689.pdf | Draft | Oral | Capsule | 018689 | 10/30/2024 |
| Avacincaptad Pegol Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217225.pdf | Draft | Intravitreal | Solution | 217225 | 02/26/2026 |
| 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/PSG_202276.pdf | Draft | Oral | Tablet | 202276 | 10/30/2024 |
| 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 | 10/30/2024 |
| Axitinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202324.pdf | Draft | Oral | Tablet | 202324 | 10/30/2024 |
| Azacitidine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050794.pdf | Draft | Intravenous, Subcutaneous | Powder | 050794 | 05/19/2021 |
| Azacitidine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214120.pdf | Draft | Oral | Tablet | 214120 | 11/16/2023 |
| 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_020428.pdf | Draft | Topical | Cream | 020428 | 08/22/2024 |
| Azelaic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021470.pdf | Draft | Topical | Gel | 021470 | 11/19/2024 |
| 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/PSG_200796.pdf | Draft | Oral | Tablet | 200796 | 10/01/2025 |
| Azilsartan Kamedoxomil; Chlorthalidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202331.pdf | Draft | Oral | Tablet | 202331 | 10/01/2025 |
| 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/PSG_050711.pdf | Draft | Oral | Tablet | 050711 050730 050784 | 10/30/2024 |
| Azithromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050693.pdf | Draft | Oral | For Suspension | 050693 | 10/30/2024 |
| Azithromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050710.pdf | Draft | Oral | For Suspension | 050710 | 10/30/2024 |
Newly Added Guidances since February 26, 2026
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Aceclidine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218585.pdf | Draft | Ophthalmic | Solution/Drops | 218585 | 02/26/2026 |
| Acetaminophen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206968.pdf | Draft | Intravenous | Solution | 206968 | 02/26/2026 |
| Acoltremon | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217370.pdf | Draft | Ophthalmic | Solution/Drops | 217370 | 02/26/2026 |
| Alpelisib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218466.pdf | Draft | Oral | Granule | 218466 | 02/26/2026 |
| Alpelisib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215039.pdf | Draft | Oral | Tablet | 215039 | 02/26/2026 |
| Apixaban | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_220073.pdf | Draft | Oral | For Suspension | 220073 | 02/26/2026 |
| Avacincaptad Pegol Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217225.pdf | Draft | Intravitreal | Solution | 217225 | 02/26/2026 |
| Buprenorphine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210136.pdf | Draft | Subcutaneous | Solution, Extended Release | 210136 | 02/26/2026 |
| Cephalexin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050440.pdf | Draft | Oral | Tablet | 063024 | 02/26/2026 |
| Dabrafenib Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217514.pdf | Draft | Oral | Tablet, For Suspension | 217514 | 02/26/2026 |
| Diazoxide Choline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216665.pdf | Draft | Oral | Tablet, Extended Release | 216665 | 02/26/2026 |
| Entrectinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218550.pdf | Draft | Oral | Pellets | 218550 | 02/26/2026 |
| Foscarbidopa; Foslevodopa | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216962.pdf | Draft | Subcutaneous | Solution | 216962 | 02/26/2026 |
| Glecaprevir; Pibrentasvir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215110.pdf | Draft | Oral | Pellets | 215110 | 02/26/2026 |
| Imatinib Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_219097.pdf | Draft | Oral | Solution | 219097 | 02/26/2026 |
| Landiolol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217202.pdf | Draft | Intravenous | Powder | 217202 | 02/26/2026 |
| Letermovir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_219104.pdf | Draft | Oral | Pellet | 219104 | 02/26/2026 |
| Meloxicam; Rizatriptan Benzoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215431.pdf | Draft | Oral | Tablet | 215431 | 02/26/2026 |
| Mometasone Furoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209310.pdf | Draft | Implantation | Implant | 209310 | 02/26/2026 |
| Paliperidone Palmitate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216352.pdf | Draft | Intramuscular | Suspension, Extended Release | 216352 | 02/26/2026 |
| Phenylephrine Hydrochloride; Tropicamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215352.pdf | Draft | Ophthalmic | Spray, Metered | 215352 | 02/26/2026 |
| Ribavirin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018859.pdf | Draft | Inhalation | For Solution | 018859 | 02/26/2026 |
| Rilpivirine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_219016.pdf | Draft | Oral | Tablet, For Suspension | 219016 | 02/26/2026 |
| Semaglutide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_218316.pdf | Draft | Oral | Tablet | 218316 | 02/26/2026 |
| Sofosbuvir; Velpatasvir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214187.pdf | Draft | Oral | Pellet | 214187 | 02/26/2026 |
| Tadalafil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214522.pdf | Draft | Oral | Suspension | 214522 | 02/26/2026 |
| Testosterone Cypionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216318.pdf | Draft | Intramuscular | Solution | 216318 | 02/26/2026 |
| Testosterone Cypionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_085635.pdf | Draft | Injection | Injectable | 085635 | 02/26/2026 |
| Tolmetin Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017628.pdf | Draft | Oral | Tablet | 017628 | 02/26/2026 |
| Tolmetin Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018084.pdf | Draft | Oral | Capsule | 018084 | 02/26/2026 |
Newly Revised Guidances since February 26, 2026
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Acetaminophen; Ibuprofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211733.pdf | Draft | Oral | Tablet | 211733 | 02/26/2026 |
| Alpelisib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212526.pdf | Draft | Oral | Tablet | 212526 | 02/26/2026 |
| Amoxicillin; Omeprazole Magnesium; Rifabutin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213004.pdf | Draft | Oral | Capsule, Delayed Release | 213004 | 02/26/2026 |
| Apixaban | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202155.pdf | Draft | Oral | Tablet | 202155 | 02/26/2026 |
| Asenapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212268.pdf | Draft | Transdermal | System | 212268 | 02/26/2026 |
| Baclofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215602.pdf | Draft | Oral | Suspension | 215602 | 02/26/2026 |
| Baloxavir Marboxil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214410.pdf | Draft | Oral | For Suspension | 214410 | 02/26/2026 |
| Barium Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208036.pdf | Draft | Oral | Suspension | 208036 | 02/26/2026 |
| Barium Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208143.pdf | Draft | Oral | Suspension | 208143 | 02/26/2026 |
| Bisoprolol Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019982.pdf | Draft | Oral | Tablet | 019982 | 02/26/2026 |
| Buprenorphine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021306.pdf | Draft | Transdermal | Film, Extended Release | 021306 | 02/26/2026 |
| Buspirone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018731.pdf | Draft | Oral | Tablet | 018731 | 02/26/2026 |
| Capsaicin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022395.pdf | Draft | Topical | Patch | 022395 | 02/26/2026 |
| Chlorthalidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012283.pdf | Draft | Oral | Tablet | 012283 218647 | 02/26/2026 |
| Clonidine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018891.pdf | Draft | Transdermal | System | 018891 | 02/26/2026 |
| Clozapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203479.pdf | Draft | Oral | Suspension | 203479 | 02/26/2026 |
| Clozapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019758.pdf | Draft | Oral | Tablet | 019758 | 02/26/2026 |
| Clozapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021590.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021590 | 02/26/2026 |
| Cobicistat; Darunavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205395.pdf | Draft | Oral | Tablet | 205395 | 02/26/2026 |
| Dasatinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021986.pdf | Draft | Oral | Tablet | 021986 | 02/26/2026 |
| Dextroamphetamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215401.pdf | Draft | Transdermal | System | 215401 | 02/26/2026 |
| Diclofenac Epolamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021234.pdf | Draft | Topical | System | 021234 | 02/26/2026 |
| Donepezil Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212304.pdf | Draft | Transdermal | System | 212304 | 02/26/2026 |
| Duloxetine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021427.pdf | Draft | Oral | Capsule, Delayed Release Pellets | 021427 | 02/26/2026 |
| Duloxetine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212516.pdf | Draft | Oral | Capsule, Delayed Release | 212516 | 02/26/2026 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020538.pdf | Draft | Transdermal | System | 020538 203752 | 02/26/2026 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019081.pdf | Draft | Transdermal | System | 019081 | 02/26/2026 |
| Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020375.pdf | Draft | Transdermal | System | 020375 021674 | 02/26/2026 |
| Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021258.pdf | Draft | Transdermal | Film, Extended Release | 021258 | 02/26/2026 |
| Estradiol; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020870.pdf | Draft | Transdermal | Film, Extended Release | 020870 | 02/26/2026 |
| Ethinyl Estradiol; Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204017.pdf | Draft | Transdermal | System | 204017 | 02/26/2026 |
| Ethinyl Estradiol; Norelgestromin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021180.pdf | Draft | Transdermal | Film, Extended Release | 021180 | 02/26/2026 |
| Fentanyl | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019813.pdf | Draft | Transdermal | Film, Extended Release | 019813 | 02/26/2026 |
| Ferric Derisomaltose | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208171.pdf | Draft | Intravenous | Solution | 208171 | 02/26/2026 |
| Formoterol Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020831.pdf | Draft | Inhalation | Powder | 020831 | 02/26/2026 |
| Granisetron | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022198.pdf | Draft | Transdermal | Film, Extended Release | 022198 | 02/26/2026 |
| Imatinib Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021588.pdf | Draft | Oral | Tablet | 021588 | 02/26/2026 |
| Ketoconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019927.pdf | Draft | Topical | Shampoo | 019927 | 02/26/2026 |
| Ketoconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020310.pdf | Draft | Topical | Shampoo | 020310 | 02/26/2026 |
| Lidocaine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207962.pdf | Draft | Topical | Patch | 207962 | 02/26/2026 |
| Lidocaine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020612.pdf | Draft | Topical | Patch | 020612 | 02/26/2026 |
| Lorazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214826.pdf | Draft | Oral | Capsule, Extended Release | 214826 | 02/26/2026 |
| Lorlatinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210868.pdf | Draft | Oral | Tablet | 210868 | 02/26/2026 |
| Loxapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022549.pdf | Draft | Inhalation | Powder | 022549 | 02/26/2026 |
| Menthol; Methyl Salicylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022029.pdf | Draft | Topical | Patch | 022029 | 02/26/2026 |
| Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020357-TabC.pdf | Draft | Oral | Tablet, Chewable | 020357 | 02/26/2026 |
| Methylphenidate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021514.pdf | Draft | Transdermal | Film, Extended Release | 021514 | 02/26/2026 |
| Nicotine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020076.pdf | Draft | Transdermal | Film, Extended Release | 020076 020165 | 02/26/2026 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020145.pdf | Draft | Transdermal | Film, Extended Release | 020145 | 02/26/2026 |
| Nitroglycerin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020144.pdf | Draft | Transdermal | Film, Extended Release | 020144 | 02/26/2026 |
| Octreotide Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213224.pdf | Draft | Subcutaneous | Solution | 213224 | 02/26/2026 |
| Oxybutynin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202211.pdf | Draft | Transdermal | Film, Extended Release | 202211 | 02/26/2026 |
| Oxybutynin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021351.pdf | Draft | Transdermal | Film, Extended Release | 021351 | 02/26/2026 |
| Paliperidone Palmitate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022264.pdf | Draft | Intramuscular | Suspension, Extended Release | 022264 | 02/26/2026 |
| Perfluorohexyloctane | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216675.pdf | Draft | Ophthalmic | Solution/Drops | 216675 | 02/26/2026 |
| Rivastigmine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022083.pdf | Draft | Transdermal | Film, Extended Release | 022083 | 02/26/2026 |
| Rotigotine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021829.pdf | Draft | Transdermal | Film, Extended Release | 021829 | 02/26/2026 |
| Sacubitril; Valsartan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207620.pdf | Draft | Oral | Tablet | 207620 | 02/26/2026 |
| Scopolamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017874.pdf | Draft | Transdermal | System | 017874 | 02/26/2026 |
| Selegiline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021336.pdf | Draft | Transdermal | Film, Extended Release | 021336 | 02/26/2026 |
| Selinexor | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212306.pdf | Draft | Oral | Tablet | 212306 | 02/26/2026 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020489.pdf | Draft | Transdermal | Film, Extended Release | 020489 | 02/26/2026 |
| Testosterone Undecanoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213953.pdf | Draft | Oral | Capsule | 213953 | 02/26/2026 |
| Testosterone Undecanoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206089.pdf | Draft | Oral | Capsule | 206089 | 02/26/2026 |
| Tiopronin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211843.pdf | Draft | Oral | Tablet, Delayed Release | 211843 | 02/26/2026 |
| Tizanidine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021447.pdf | Draft | Oral | Capsule | 021447 | 02/26/2026 |
| Venlafaxine Besylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215429.pdf | Draft | Oral | Tablet, Extended Release | 215429 | 02/26/2026 |
| Venlafaxine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020151.pdf | Draft | Oral | Tablet | 020151 | 02/26/2026 |