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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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.
1
2
Total number of currently published PSGs: 2187
128 record(s) found for 'B'
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Bacitracin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bacitracin_ophthalmic ointment_RLD61212_RV09-16.pdf | Draft | Ophthalmic | Ointment | 061212 | 10/04/2016 |
| Baclofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021589.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021589 | 11/21/2019 |
| Baclofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Baclofen_tab_72235_72234_RC2-10.pdf | Draft | Oral | Tablet | 017851 | 02/25/2010 |
| Baclofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215422.pdf | Draft | Oral | Granules | 215422 | 02/15/2024 |
| Baloxavir Marboxil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214410.pdf | Draft | Oral | For Suspension | 214410 | 05/18/2023 |
| Baloxavir Marboxil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210854.pdf | Draft | Oral | Tablet | 210854 | 05/18/2023 |
| Balsalazide Disodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Balsalazide_disodium_tab_022205_RC06-13.pdf | Draft | Oral | Tablet | 022205 | 06/19/2013 |
| Balsalazide Disodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Balsalazide_cap_20610_RC1-08.pdf | Draft | Oral | Capsule | 020610 | 01/01/2008 |
| Baricitinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207924.pdf | Draft | Oral | Tablet | 207924 | 11/17/2022 |
| Barium Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Barium sulfate_oral paste_NDA 208844_RC08-17.pdf | Draft | Oral | Paste | 208844 | 10/19/2017 |
| Barium Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Barium sulfate_oral supension_NDA 208036_RC11-17.pdf | Draft | Oral | Suspension | 208036 | 02/08/2018 |
| Barium Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Barium sulfate_oral supension_NDA 208143_RC11-17.pdf | Draft | Oral | Suspension | 208143 | 02/08/2018 |
| Beclomethasone Dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207921.pdf | Draft | Inhalation | Aerosol, Metered | 207921 | 08/21/2023 |
| Beclomethasone Dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020911.pdf | Draft | Inhalation | Aerosol, Metered | 020911 | 08/21/2023 |
| Beclomethasone Dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Beclomethasone dipropionate_draft_Nasal aerosol metered_RLD 202813_RC07-18.pdf | Draft | Nasal | Aerosol, Metered | 202813 | 07/20/2018 |
| Beclomethasone Dipropionate Monohydrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019389.pdf | Draft | Nasal | Spray, Metered | 019389 | 08/21/2023 |
| Bedaquiline Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bedaquiline_fumarate_tab_204384_RC11-13.pdf | Draft | Oral | Tablet | 204384 | 11/05/2013 |
| Belumosudil Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214783.pdf | Draft | Oral | Tablet | 214783 | 05/18/2023 |
| Belzutifan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215383.pdf | Draft | Oral | Tablet | 215383 | 05/18/2023 |
| Bempedoic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211616.pdf | Draft | Oral | Tablet | 211616 | 11/08/2021 |
| Bempedoic Acid; Ezetimibe | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211617.pdf | Draft | Oral | Tablet | 211617 | 11/08/2021 |
| Benazepril Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benazepril_HCl_tabs_19851_RC07-10.pdf | Draft | Oral | Tablet | 019851 | 07/28/2010 |
| Benazepril Hydrochloride; Hydrochlorothiazide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benazepril HCL and hydrochlorothiazide_oral tablet_20033_RC09-15.pdf | Draft | Oral | Tablet | 020033 | 09/18/2015 |
| Benoxinate hydrochloride; Fluorescein sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benoxinate hydrochloride; Fluorescein sodium Ophthalmic solution drops 0.25-0.45 NDA 208582 PSG Page RC May 2019.pdf | Draft | Topical | Solution/Drops | 208582 | 05/15/2019 |
| Benznidazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Beznidazole Oral Tablets NDA 209570 RC 09-2018.pdf | Draft | Oral | Tablet | 209570 | 09/13/2018 |
| Benzonatate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzonatate _oral capsule_040749 040627 201209_RV09-15.pdf | Draft | Oral | Capsule | 011210 | 09/18/2015 |
| Benzoyl Peroxide; Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050819.pdf | Draft | Topical | Gel | 050819 | 02/16/2023 |
| Benzoyl Peroxide; Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050741.pdf | Draft | Topical | Gel | 050741 | 02/16/2023 |
| Benzoyl Peroxide; Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050756.pdf | Draft | Topical | Gel | 050756 | 02/16/2023 |
| Benzoyl Peroxide; Erythromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050557.pdf | Draft | Topical | Gel | 050557 | 11/21/2019 |
| Benzoyl Peroxide; Erythromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050769.pdf | Draft | Topical | Gel | 050769 | 11/21/2019 |
| Benzphetamine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Benzphetamine_HCl_tab_12427_RC5-06.pdf | Final | Oral | Tablet | 012427 | 05/01/2008 |
| Benztropine Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009193.pdf | Draft | Oral | Tablet | 009193 | 09/16/2019 |
| Benzyl Alcohol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022129.pdf | Draft | Topical | Lotion | 022129 | 10/21/2022 |
| Berotralstat Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214094.pdf | Draft | Oral | Capsule | 214094 | 08/02/2022 |
| Besifloxacin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022308.pdf | Draft | Ophthalmic | Suspension/Drops | 022308 | 03/02/2020 |
| Betamethasone Acetate; Betamethasone Sodium Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_014602.pdf | Draft | Injection | Injectable | 014602 | 11/16/2023 |
| Betamethasone dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_topical Lotion_NDA 01778_RC08-17.pdf | Draft | Topical | Lotion | 017781 | 10/19/2017 |
| Betamethasone dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone Dipropionate_topical cream 0.05_RLD 019137_RC09-16.pdf | Draft | Topical | Cream | 019137 | 10/04/2016 |
| Betamethasone dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_ topical augmented cream_RLD 19555_RC04-16.pdf | Draft | Topical | Cream, Augmented | 019555 | 04/14/2016 |
| Betamethasone dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_topical augmented lotion_RLD 019716_RC01-16.pdf | Draft | Topical | Lotion, Augmented | 019716 | 01/27/2016 |
| Betamethasone dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_topical augmented ointment_NDA 018741_RC11-17.pdf | Draft | Topical | Ointment, Augmented | 018741 | 02/08/2018 |
| Betamethasone dipropionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone dipropionate_draft_Topical spray_RLD 208079_RC07-18.pdf | Draft | Topical | Spray | 208079 | 07/20/2018 |
| Betamethasone Dipropionate; Calcipotriene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213422.pdf | Draft | Topical | Cream | 213422 | 10/21/2022 |
| Betamethasone Dipropionate; Calcipotriene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207589.pdf | Draft | Topical | Aerosol, Foam | 207589 | 11/21/2019 |
| Betamethasone Dipropionate; Calcipotriene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021852.pdf | Draft | Topical | Ointment | 021852 | 10/21/2022 |
| Betamethasone Dipropionate; Calcipotriene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022185.pdf | Draft | Topical | Suspension | 022185 | 10/21/2022 |
| Betamethasone Dipropionate; Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020010.pdf | Draft | Topical | Lotion | 020010 076493 | 02/15/2024 |
| Betamethasone Dipropionate; Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018827.pdf | Draft | Topical | Cream | 018827 075673 | 02/15/2024 |
| Betamethasone Valerate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone valerate_topical cream_RLD 018861_RC12-16.pdf | Draft | Topical | Cream | 018861 | 12/22/2016 |
| Betamethasone Valerate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone valerate_topical ointment_RLD 18865_RC10-16.pdf | Draft | Topical | Ointment | 018865 | 10/04/2016 |
| Betamethasone Valerate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone_valerate_aerofoam_20934_RC12-14.pdf | Draft | Topical | Aerosol, Foam | 020934 | 12/29/2014 |
| Betamethasone Valerate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betamethasone valerate_topical lotion_RLD 018866_RC01-16.pdf | Draft | Topical | Lotion | 018866 | 01/27/2016 |
| Betaxolol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/BETAXOLOL HYDROCHLORIDE ophthalmic suspensiondrops NDA 019845 PSG Page RV May 2019.pdf | Draft | Ophthalmic | Solution/Drops | 019845 | 05/15/2019 |
| Bethanechol Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bethanechol_Chloride_tab_88440_88441_89096_89095_RC9-08.pdf | Draft | Oral | Tablet | 006536 | 09/01/2008 |
| Betrixaban | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Betrixaban_draft_Oral cap_RLD 208383_RC07-18.pdf | Draft | Oral | Capsule | 208383 | 07/20/2018 |
| Bexarotene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021056.pdf | Draft | Topical | Gel | 021056 | 10/21/2022 |
| Bexarotene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf | Draft | Oral | Capsule | 021055 | 08/20/2021 |
| Bicalutamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bicalutamide_tab_20498_RC5-05.pdf | Final | Oral | Tablet | 020498 | 05/01/2008 |
| Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bictegravir Sodium, Emtricitabin, Tenofovir Alafenamide Fumarate Oral Tablet NDA 210251 page RC May 2019.pdf | Draft | Oral | Tablet | 210251 | 05/15/2019 |
| Bimatoprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211911.pdf | Draft | Ophthalmic | Implant | 211911 | 05/18/2023 |
| Bimatoprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bimatoprost_ophthalmic solution drops_NDA 021275_RC11-17.pdf | Draft | Ophthalmic | Solution/Drops | 021275 | 02/08/2018 |
| Bimatoprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bimatoprost_ophthalmic solution drops_NDA 022184_RC11-17.pdf | Draft | Ophthalmic | Solution/Drops | 022184 | 02/08/2018 |
| Bimatoprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bimatoprost_ophthalmic solution drops_NDA 022369_RC11-17.pdf | Draft | Topical | Solution/Drops | 022369 | 02/08/2018 |
| Binimetinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210498.pdf | Draft | Oral | Tablet | 210498 | 03/02/2020 |
| Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bisacodyl; PEG3350_ANDA 202217_RC03-17.pdf | Draft | Oral | For Solution, Tablet, Delayed Release | 021551 | 05/16/2017 |
| Bismuth Subcitrate Potassium; Metronidazole;Tetracycline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/BismuthSubcitratePotassiumMetronidazoleTetracyclineHClcap50786RC908.pdf | Draft | Oral | Capsule | 050786 | 09/01/2008 |
| Bismuth Subsalicylate; Metronidazole; Tetracycline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050719.pdf | Draft | Oral | Tablet, Chewable, Tablet, Capsule | 050719 | 02/16/2023 |
| Bisoprolol Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bisoprolol_Fumarate_tab_19982_RC7-05..pdf | Final | Oral | Tablet | 019982 | 05/01/2008 |
| Bisoprolol Fumarate; Hydrochlorothiazide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bisoprolol_Fumarate_HCTZ_tab_20186_RC7-05.pdf | Final | Oral | Tablet | 020186 | 05/01/2008 |
| Boceprevir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Boceprevir_Cap_202258_RC06-12.pdf | Draft | Oral | Capsule | 202258 | 06/01/2012 |
| Bortezomib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021602.pdf | Draft | Intravenous, Subcutaneous | Injectable | 021602 | 08/28/2020 |
| Bosentan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bosentan_tabs_21290_RC09-10.pdf | Draft | Oral | Tablet | 021290 | 03/28/2012 |
| Bosentan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bosentan Tablets for oral suspension NDA 209279 RC Feb 2019.pdf | Draft | Oral | Tablet, For Suspension | 209279 | 02/22/2019 |
| Bosutinib Monohydrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203341.pdf | Draft | Oral | Tablet | 203341 | 09/16/2019 |
| Bremelanotide Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210557.pdf | Draft | Subcutaneous | Solution | 210557 | 03/24/2021 |
| Brexanolone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211371.pdf | Draft | Intravenous | Solution | 211371 | 06/03/2020 |
| Brexpiprazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brexpiprizole_oral tablet_NDA 205422_RC05-17.pdf | Draft | Oral | Tablet | 205422 | 07/13/2017 |
| Brigatinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brigatinib_draft_Oral tab_RLD 208772_RC09-18.pdf | Draft | Oral | Tablet | 208772 | 09/13/2018 |
| Brilliant Blue G | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209569.pdf | Draft | Ophthalmic | Solution | 209569 | 12/17/2021 |
| Brimonidine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate ophthalmic solution 0.025 NDA 208144 PSG Page RC May 2019.pdf | Draft | Ophthalmic | Solution/Drops | 208144 | 05/15/2019 |
| Brimonidine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate_ophthalmic solution_NDA 021770_RV08-17.pdf | Draft | Ophthalmic | Solution/Drops 0.1% | 021770 | 10/19/2017 |
| Brimonidine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate_ophthalmic solution_NDA 020613_RV08-17.pdf | Draft | Ophthalmic | Solution/Drops 0.2% | 020613 | 10/19/2017 |
| Brimonidine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate_topical gel_204708_RC09-15.pdf | Draft | Topical | Gel | 204708 | 09/18/2015 |
| Brimonidine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine Tartrate_Ophthalmic Solution_NDA 021262_RV07-17.pdf | Draft | Ophthalmic | Solution/Drops 0.15% | 021262 | 07/13/2017 |
| Brimonidine Tartrate; Brinzolamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/BRIMONIDINE TARTRATE BRINZOLAMIDE ophthalmic suspension drops NDA 204251 PSG Page RV May 2019.pdf | Draft | Ophthalmic | Suspension/Drops | 204251 | 05/15/2019 |
| Brimonidine Tartrate;Timolol Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brimonidine tartrate Timolol MaleateNDA 021398 RC 09-2018.pdf | Draft | Ophthalmic | Solution/Drops | 021398 | 09/13/2018 |
| Brincidofovir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214460.pdf | Draft | Oral | Suspension | 214460 | 05/18/2023 |
| Brincidofovir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214461.pdf | Draft | Oral | Tablet | 214461 | 05/18/2023 |
| Brinzolamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/BRINZOLAMIDE ophthalmic suspension drops NDA 020816 PSG Page RV May 2019.pdf | Draft | Ophthalmic | Suspension/Drops 1% | 020816 | 05/15/2019 |
| Brivaracetam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Brivaracetam_oral tablet_NDA 205836_RC05-17.pdf | Draft | Oral | Tablet | 205836 | 07/13/2017 |
| Bromfenac Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromfenac sodium_ophthalmic solution_NDA 021664_RV08-17.pdf | Draft | Ophthalmic | Solution/Drops | 021664 | 10/19/2017 |
| Bromocriptine Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine_ Mesylate_cap_17962_RC11-09.pdf | Draft | Oral | Capsule | 017962 | 11/30/2009 |
| Bromocriptine Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine_ Mesylate_tab_17962_RC11-09.pdf | Draft | Oral | Tablet | 017962 | 11/23/2009 |
| Bromocriptine mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine Mesylate Tablets NDA20866 RC Feb 2019.pdf | Draft | Oral | Tablet | 020866 | 02/22/2019 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205613.pdf | Draft | Rectal | Aerosol, Foam | 205613 | 11/18/2020 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021324.pdf | Draft | Oral | Capsule, Delayed Release | 021324 | 08/20/2021 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215935.pdf | Draft | Oral | Capsule, Delayed Release | 215935 | 11/17/2022 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211929.pdf | Draft | Oral | Capsule, Extended Release | 211929 | 03/02/2020 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020746.pdf | Draft | Nasal | Spray, Metered | 020746 | 08/21/2023 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf | Draft | Inhalation | Powder, Metered | 021949 | 02/15/2024 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_Inhalation_Sus_20929_RC_09-12.pdf | Draft | Inhalation | Suspension | 020929 | 09/19/2012 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_ERTab_203634_RC12-14.pdf | Draft | Oral | Tablet, Extended Release | 203634 | 12/10/2014 |
| Budesonide; Formoterol Fumarate Dihydrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021929.pdf | Draft | Inhalation | Aerosol, Metered | 021929 | 11/16/2023 |
| Budesonide; Formoterol Fumarate; Glycopyrrolate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212122.pdf | Draft | Inhalation | Aerosol, Metered | 212122 | 02/15/2024 |
| Bumetanide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bumetanide_tab_74700_RV11-13.pdf | Draft | Oral | Tablet | 018225 | 11/05/2013 |
| Bupivacaine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupivacaine_ liposomal injectable injection_NDA 022496_RC11-17.pdf | Draft | Injection | Injectable, Liposomal | 022496 | 02/08/2018 |
| Bupivacaine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204803.pdf | Draft | Infiltration | Solution, Extended Release | 204803 | 05/19/2022 |
| Buprenorphine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209819.pdf | Draft | Subcutaneous | Solution, Extended Release | 209819 | 06/03/2020 |
| Buprenorphine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021306.pdf | Draft | Transdermal | Film, Extended Release | 021306 | 06/03/2020 |
| Buprenorphine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine_hydrochloride_SLtab_78633_RV02-14.pdf | Draft | Sublingual | Tablet | 020732 | 02/01/2014 |
| Buprenorphine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine hydrochloride_buccal film_NDA 207932_RC11-17.pdf | Draft | Buccal | Film | 207932 | 02/08/2018 |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine HCL_Naloxone HCL_Buccal Film_205637_RC03-15.pdf | Draft | Buccal | Film | 205637 | 03/06/2015 |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine HCL; Naloxone HCL_sublingual buccal film_RLD 022410_RV12-16.pdf | Draft | Buccal, Sublingual | Film | 022410 | 12/22/2016 |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine_HCl;_Naloxone_HCl_subtab_20733_RC5-10.pdf | Draft | Sublingual | Tablet | 020733 | 05/20/2010 |
| Buprenorphine Hydrochloride; Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine Hcl; Naloxone Hcl_sublingual tablet_RLD 204242_RV12-16.pdf | Draft | Sublingual | Tablet | 204242 | 12/22/2016 |
| Bupropion Hydrobromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HBr_ERtab_22108_RV03-13.pdf | Draft | Oral | Tablet, Extended Release | 022108 | 03/29/2013 |
| Bupropion Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_ERtab_22497_RC03-13.pdf | Draft | Oral | Tablet, Extended Release | 022497 | 03/29/2013 |
| Bupropion Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_tab_18644_RV03-13.pdf | Draft | Oral | Tablet | 018644 | 03/29/2013 |
| Bupropion Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_ERtab_21515_RV03-13.pdf | Draft | Oral | Tablet, Extended Release | 021515 | 03/29/2013 |
| Bupropion Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bupropion_HCl_ERtab_20358_20711_RV03-13.pdf | Draft | Oral | Tablet, Extended Release | 020358 020711 | 03/29/2013 |
| Bupropion Hydrochloride; Naltrexone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200063.pdf | Draft | Oral | Tablet, Extended Release | 200063 | 11/18/2020 |
| Buspirone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buspirone_tab_18731_RC12-09.pdf | Draft | Oral | Tablet | 018731 | 12/17/2009 |
| Busulfan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Busulfan_tab_09386_RC7-08.pdf | Draft | Oral | Tablet | 009386 | 07/01/2009 |
| Butenafine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020524.pdf | Draft | Topical | Cream | 020524 | 10/21/2022 |
| Butenafine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021307.pdf | Draft | Topical | Cream | 021307 | 10/21/2022 |
| Butoconazole Nitrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Butoconazole Nitrate Vaginal Cream ANDA 200923 RV Feb 2019.pdf | Draft | Vaginal | Cream | 200923 | 02/22/2019 |
| Butoconazole Nitrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Butoconazole Nitrate Vaginal Cream NDA 020421 RV Feb 2019.pdf | Draft | Vaginal | Cream | 020421 | 02/22/2019 |
Newly Added Guidances since February 15, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215413.pdf | Draft | Oral | Tablet, For Suspension | 215413 | 02/15/2024 |
| Adagrasib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216340.pdf | Draft | Oral | Tablet | 216340 | 02/15/2024 |
| Amoxicillin; Clarithromycin; Vonoprazan Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215152.pdf | Draft | Oral | Capsule, Tablet, Tablet | 215152 | 02/15/2024 |
| Amoxicillin; Vonoprazan Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215153.pdf | Draft | Oral | Capsule, Tablet | 215153 | 02/15/2024 |
| Baclofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215422.pdf | Draft | Oral | Granules | 215422 | 02/15/2024 |
| Budesonide; Formoterol Fumarate; Glycopyrrolate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212122.pdf | Draft | Inhalation | Aerosol, Metered | 212122 | 02/15/2024 |
| Caffeine; Ergotamine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_086557.pdf | Draft | Rectal | Suppository | 086557 009000 | 02/15/2024 |
| Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216974.pdf | Draft | Intravenous | Powder | 216974 | 02/15/2024 |
| Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213388.pdf | Draft | Oral | Capsule | 213388 | 02/15/2024 |
| Ferric Derisomaltose | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208171.pdf | Draft | Intravenous | Solution | 208171 | 02/15/2024 |
| Finasteride; Tadalafil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215423.pdf | Draft | Oral | Capsule | 215423 | 02/15/2024 |
| Flotufolastat F-18 Gallium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216023.pdf | Draft | Intravenous | Solution | 216023 | 02/15/2024 |
| Formoterol Fumarate; Glycopyrrolate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208294.pdf | Draft | Inhalation | Aerosol, Metered | 208294 | 02/15/2024 |
| Lenacapavir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215974.pdf | Draft | Oral | Tablet | 215974 | 02/15/2024 |
| Lenacapavir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215973.pdf | Draft | Subcutaneous | Solution | 215973 | 02/15/2024 |
| Mannitol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022368.pdf | Draft | Inhalation | Powder | 022368 | 02/15/2024 |
| Mannitol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202049.pdf | Draft | Inhalation | Powder | 202049 | 02/15/2024 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208969.pdf | Draft | Nasal | Spray, Metered | 208969 | 02/15/2024 |
| Niraparib Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214876.pdf | Draft | Oral | Tablet | 214876 | 02/15/2024 |
| Olutasidenib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215814.pdf | Draft | Oral | Capsule | 215814 | 02/15/2024 |
| Oxymetazoline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212520.pdf | Draft | Ophthalmic | Solution/Drops | 212520 | 04/02/2024 |
| Rivaroxaban | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215859.pdf | Draft | Oral | For Suspension | 215859 | 02/15/2024 |
| Sertraline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215133.pdf | Draft | Oral | Capsule | 215133 | 02/15/2024 |
| Sodium Phenylbutyrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214860.pdf | Draft | Oral | For Suspension | 214860 | 02/15/2024 |
| Sodium Phenylbutyrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216513.pdf | Draft | Oral | Pellets | 216513 | 02/15/2024 |
| Sodium Phenylbutyrate; Taurursodiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216660.pdf | Draft | Oral | For Suspension | 216660 | 02/15/2024 |
| Terlipressin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022231.pdf | Draft | Intravenous | Powder | 022231 | 02/15/2024 |
| Testosterone Undecanoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213953.pdf | Draft | Oral | Capsule | 213953 | 02/15/2024 |
| Xenon Xe-129 Hyperpolarized | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214375.pdf | Draft | Inhalation | Gas | 214375 | 02/15/2024 |
| Zanamivir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021036.pdf | Draft | Inhalation | Powder | 021036 | 02/15/2024 |
Newly Revised Guidances since February 15, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Aclidinium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202450.pdf | Draft | Inhalation | Powder, Metered | 202450 | 02/15/2024 |
| Aclidinium Bromide; Formoterol Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210595.pdf | Draft | Inhalation | Powder, Metered | 210595 | 02/15/2024 |
| Albuterol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf | Draft | Inhalation | Powder, Metered | 205636 | 02/15/2024 |
| Aprepitant | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf | Draft | Intravenous | Emulsion | 209296 216457 | 02/15/2024 |
| Betamethasone Dipropionate; Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020010.pdf | Draft | Topical | Lotion | 020010 076493 | 02/15/2024 |
| Betamethasone Dipropionate; Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018827.pdf | Draft | Topical | Cream | 018827 075673 | 02/15/2024 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf | Draft | Inhalation | Powder, Metered | 021949 | 02/15/2024 |
| Dapsone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207154.pdf | Draft | Topical | Gel | 207154 | 02/15/2024 |
| Dapsone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021794.pdf | Draft | Topical | Gel | 021794 | 02/15/2024 |
| Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050023.pdf | Draft | Ophthalmic | Suspension/Drops | 050023 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050616.pdf | Draft | Ophthalmic | Ointment | 050616 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050592.pdf | Draft | Ophthalmic | Suspension/Drops | 050592 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050818.pdf | Draft | Ophthalmic | Suspension/Drops | 050818 | 02/15/2024 |
| Diazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211635.pdf | Draft | Nasal | Spray | 211635 | 02/15/2024 |
| Doxepin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022036.pdf | Draft | Oral | Tablet | 022036 | 02/15/2024 |
| Ferric Carboxymaltose | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203565.pdf | Draft | Intravenous | Solution | 203565 | 02/15/2024 |
| Fluorometholone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016851.pdf | Draft | Ophthalmic | Suspension/Drops | 016851 | 02/15/2024 |
| Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf | Draft | Inhalation | Powder | 209482 | 02/15/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf | Draft | Inhalation | Powder | 208798 | 02/15/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf | Draft | Inhalation | Powder | 020833 | 02/15/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf | Draft | Inhalation | Powder | 021077 | 02/15/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf | Draft | Inhalation | Powder | 208799 | 02/15/2024 |
| Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060613.pdf | Draft | Otic | Suspension/Drops | 060613 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf | Draft | Ophthalmic | Suspension/Drops | 020583 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200738.pdf | Draft | Ophthalmic | Ointment | 200738 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020803.pdf | Draft | Ophthalmic | Suspension/Drops | 020803 | 02/15/2024 |
| Loteprednol Etabonate; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050804.pdf | Draft | Ophthalmic | Suspension/Drops | 050804 | 02/15/2024 |
| Mometasone Furoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf | Draft | Inhalation | Powder | 021067 | 02/15/2024 |
| Nilotinib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022068.pdf | Draft | Oral | Capsule | 022068 | 02/15/2024 |
| Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020692.pdf | Draft | Inhalation | Powder | 020692 | 02/15/2024 |
| Umeclidinium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205382.pdf | Draft | Inhalation | Powder | 205382 | 02/15/2024 |
| Umeclidinium Bromide; Vilanterol Trifenatate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203975.pdf | Draft | Inhalation | Powder | 203975 | 02/15/2024 |
| Vandetanib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022405.pdf | Draft | Oral | Tablet | 022405 | 02/15/2024 |