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Product-Specific Guidances for Generic Drug Development

To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use; bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its RLD.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence (BE) for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate BE depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct BE testing using the most accurate, sensitive, and reproducible approach available among those set forth in 21 CFR 320.24. As the initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).

To facilitate generic drug product availability and further assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, the FDA publishes product-specific guidances (PSG). PSGs describe the Agency's current thinking and expectations to develop generic drug products therapeutically equivalent to specific RLDs.

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

PSGs are published in an incremental manner and listed below in alphabetical order according to the active ingredient's name. The most recently published guidances (new and revised) are listed below.

The implementation of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 20221 (GDUFA III). with regard to issuance of PSGs is effective on October 1, 2022. Under GDUFA III, the FDA will issue PSGs consistent with the following goals:

  • For complex products1,2 approved in new drug applications (NDAs) on or after October 1, 2022, a PSG will be issued for 50 percent of such NDA products within two years after the date of approval, and for 75 percent of such NDA products within three years after the date of approval.
  • FDA will continue to develop PSGs for complex products approved prior to October 1, 2022, for which no PSG has been published.
  • For non-complex drug products approved in NDAs on or after October 1, 2022, that contain a new chemical entity (NCE) (as described in section 505(j)(5)(F)(ii) of the FD&C Act), a PSG will be issued within two years after the date of approval for 90 percent of such products.
In addition to GDUFA III PSG goals, the FDA considers several factors when prioritizing PSG development. The FDA evaluates the generic industries and other stakeholders' interest in products that do not have a PSG through controlled correspondences, public requests, and pre-ANDA meeting requests.

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

Sponsors and investigators of any investigational new drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or BE and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct, including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or BE and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct; including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring.

Some of the PSGs include discussion regarding data formats. Please note that under section 745A(a) of the Federal Food, Drug, and Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified must be used for submissions to ANDAs. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at esub@fda.hhs.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

COMMENTS: The Agency is seeking feedback and considers comments to the docket on these guidances. You may submit comments on any guidance at any time as follows: Submit electronic comments to Docket FDA-2007-D-0369. For further information on submitting electronic comments, refer to (www.regulations.gov). You may also mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions received must include the Docket No. [FDA-2007-D-0369]. Please contact the Regulations.gov Help Desk at 1-877-378-5457 (toll free) or at (www.regulations.gov/support) for assistance regarding submissions.

The FDA posts plans for issuing new or revised PSGs on the Upcoming Product-Specific Guidances for Generic Drug Product Development web page

For additional information on development of generic drug products, please refer to FDA's guidance document database.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III Commitment Letter)

2Classifying Approved New Drug Products and Drug-device combination Products as Complex Products for Generic Drug Development Purposes (CDER MAPP 5240.10)

Total number of currently published PSGs: 2223

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


130 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_215422.pdf Draft Oral Granules 215422 02/15/2024
Baclofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215602.pdf Draft Oral Suspension 215602 05/16/2024
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_021589.pdf Draft Oral Tablet, Orally Disintegrating 021589 11/21/2019
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 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
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
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 08/22/2024
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 05/16/2024
Benzoyl Peroxide; Erythromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050769.pdf Draft Topical Gel 050769 05/16/2024
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 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 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; 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_022185.pdf Draft Topical Suspension 022185 10/21/2022
Betamethasone Dipropionate; Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021852.pdf Draft Topical Ointment 021852 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_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
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
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
Bexagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214373.pdf Draft Oral Tablet 214373 05/16/2024
Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf Draft Oral Capsule 021055 08/20/2021
Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021056.pdf Draft Topical Gel 021056 10/21/2022
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/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
Bimatoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211911.pdf Draft Ophthalmic Implant 211911 05/18/2023
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 Tablets for oral suspension NDA 209279 RC Feb 2019.pdf Draft Oral Tablet, For Suspension 209279 02/22/2019
Bosentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bosentan_tabs_21290_RC09-10.pdf Draft Oral Tablet 021290 03/28/2012
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_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 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_Ophthalmic Solution_NDA 021262_RV07-17.pdf Draft Ophthalmic Solution/Drops 0.15% 021262 07/13/2017
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; 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_214461.pdf Draft Oral Tablet 214461 05/18/2023
Brincidofovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214460.pdf Draft Oral Suspension 214460 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_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
Bromocriptine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Bromocriptine_ Mesylate_cap_17962_RC11-09.pdf Draft Oral Capsule 017962 11/30/2009
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/Budesonide_Inhalation_Sus_20929_RC_09-12.pdf Draft Inhalation Suspension 020929 09/19/2012
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 08/22/2024
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/PSG_204803.pdf Draft Infiltration Solution, Extended Release 204803 05/19/2022
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
Buprenorphine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021306.pdf Draft Transdermal Film, Extended Release 021306 06/03/2020
Buprenorphine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209819.pdf Draft Subcutaneous Solution, Extended Release 209819 06/03/2020
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 https://www.accessdata.fda.gov/drugsatfda_docs/psg/Buprenorphine_hydrochloride_SLtab_78633_RV02-14.pdf Draft Sublingual Tablet 020732 02/01/2014
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
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
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_ERtab_21515_RV03-13.pdf Draft Oral Tablet, Extended Release 021515 03/29/2013
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020358.pdf Draft Oral Tablet, Extended Release 020358 020711 08/22/2024
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; 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 August 22, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Air Polymer-Type A https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212279.pdf Draft Intrauterine Foam 212279 08/22/2024
Fezolinetant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216578.pdf Draft Oral Tablet 216578 08/22/2024
Heparin Sodium; Taurolidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214520.pdf Draft N/A Solution 214520 08/22/2024
Leniolisib Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217759.pdf Draft Oral Tablet 217759 08/22/2024
Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217722.pdf Draft Nasal Spray, Metered 217722 08/22/2024
Nedosiran Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215842.pdf Draft Injection Solution 215842 08/22/2024
Nirmatrelvir; Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217188.pdf Draft Oral Tablet; Tablet 217188 08/22/2024
Pegcetacoplan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217171.pdf Draft Intravitreal Solution 217171 08/22/2024
Risperidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212849.pdf Draft Intramuscular For Suspension, Extended Release 212849 08/22/2024
Sotagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216203.pdf Draft Oral Tablet 216203 08/22/2024
Tafluprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202514.pdf Draft Ophthalmic Solution, Drops 202514 08/22/2024
Teriparatide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021318.pdf Draft Subcutaneous Solution 021318 08/22/2024
Tofersen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215887.pdf Draft Intrathecal Solution 215887 08/22/2024
Trofinetide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217026.pdf Draft Oral Solution 217026 08/22/2024

Newly Revised Guidances since August 22, 2024

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Albuterol Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf Draft Inhalation Aerosol, Metered 020503 020983 021457 08/22/2024
Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/22/2024
Apalutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210951.pdf Draft Oral Tablet 210951 08/22/2024
Azelaic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020428.pdf Draft Topical Cream 020428 08/22/2024
Bempedoic Acid; Ezetimibe https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211617.pdf Draft Oral Tablet 211617 08/22/2024
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf Draft Inhalation Powder, Metered 021949 08/22/2024
Bupropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020358.pdf Draft Oral Tablet, Extended Release 020358 020711 08/22/2024
Carvedilol Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022012.pdf Draft Oral Capsule, Extended Release 022012 08/22/2024
Ciprofloxacin Hydrochloride; Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020805.pdf Draft Otic Suspension/Drops 020805 08/22/2024
Ciprofloxacin; Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021537.pdf Draft Otic Suspension/Drops 021537 08/22/2024
Cladribine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022561.pdf Draft Oral Tablet 022561 08/22/2024
Dalfampridine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022250.pdf Draft Oral Tablet, Extended Release 022250 08/22/2024
Dapagliflozin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205649.pdf Draft Oral Tablet, Extended Release 205649 08/22/2024
Donepezil Hydrochloride; Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206439.pdf Draft Oral Capsule, Extended Release 206439 08/22/2024
Fentanyl Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022569.pdf Draft Nasal Spray, Metered 022569 08/22/2024
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/22/2024
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf Draft Inhalation Powder 209482 08/22/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021433.pdf Draft Inhalation Aerosol, Metered 021433 08/22/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf Draft Inhalation Powder 020833 08/22/2024
Fluticasone Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf Draft Inhalation Powder 208798 08/22/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf Draft Inhalation Powder 208799 08/22/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021254.pdf Draft Inhalation Aerosol, Metered 021254 08/22/2024
Fluticasone Propionate; Salmeterol Xinafoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf Draft Inhalation Powder 021077 08/22/2024
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019968.pdf Draft Topical Ointment 019968 08/22/2024
Hydrochlorothiazide; Metoprolol Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021956.pdf Draft Oral Tablet, Extended Release 021956 08/22/2024
Hydromorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021217.pdf Draft Oral Tablet, Extended Release 021217 08/22/2024
Ibrutinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210563.pdf Draft Oral Tablet 210563 08/22/2024
Levalbuterol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021730.pdf Draft Inhalation Aerosol, Metered 021730 08/22/2024
Levomilnacipran Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204168.pdf Draft Oral Capsule, Extended Release 204168 08/22/2024
Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022525.pdf Draft Oral Capsule, Extended Release 022525 08/22/2024
Metformin Hydrochloride; Sitagliptin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202270.pdf Draft Oral Tablet, Extended Release 202270 08/22/2024
Metformin Hydrochloride;Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200678.pdf Draft Oral Tablet, Extended Release 200678 08/22/2024
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf Draft Inhalation Powder 021067 08/22/2024
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019516.pdf Draft Oral Tablet, Extended Release 019516 08/22/2024
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021260.pdf Draft Oral Capsule, Extended Release 079040 08/22/2024
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020616.pdf Draft Oral Capsule, Extended Release 020616 08/22/2024
Naloxone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208411.pdf Draft Nasal Spray, Metered 208411 08/22/2024
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/22/2024
Olodaterol Hydrochloride; Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206756.pdf Draft Inhalation Spray, Metered 206756 08/22/2024
Oxcarbazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202810.pdf Draft Oral Tablet, Extended Release 202810 08/22/2024
Oxymorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021610.pdf Draft Oral Tablet, Extended Release 021610 08/22/2024
Phentermine Hydrochloride;Topiramate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022580.pdf Draft Oral Capsule, Extended Release 022580 08/22/2024
Posaconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205053.pdf Draft Oral Tablet, Delayed Release 205053 08/22/2024
Pramipexole Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022421.pdf Draft Oral Tablet, Extended Release 022421 08/22/2024
Progesterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022057.pdf Draft Vaginal Insert 022057 08/22/2024
Promethazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010926.pdf Draft Rectal Suppository 010926 08/22/2024
Quetiapine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022047.pdf Draft Oral Tablet, Extended Release 022047 08/22/2024
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206406.pdf Draft Oral Tablet, Extended Release 206406 08/22/2024
Tapentadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200533.pdf Draft Oral Tablet, Extended Release 200533 08/22/2024
Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021936.pdf Draft Inhalation Spray, Metered 021936 08/22/2024
Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021692.pdf Draft Oral Tablet, Extended Release 021692 08/22/2024
Trospium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022103.pdf Draft Oral Capsule, Extended Release 022103 08/22/2024
Venlafaxine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022104.pdf Draft Oral Tablet, Extended Release 022104 08/22/2024
Verteporfin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021119.pdf Draft Injection Injectable 021119 08/22/2024
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