Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to, the filenames for product-specific guidances on this web page may not match the corresponding guidance titles. In such cases, the name on the document correctly identifies the title of the guidance. These discrepancies will be corrected as soon as possible.

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 reference listed drug.

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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).

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

FDA publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs.

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

Additionally, as part of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference listed drugs that are (1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to the earliest lawful ANDA filing date. 1 This goal does not include complex products as defined in the GDUFA II Commitment Letter. FDA will strive to issue guidance for a complex product as soon as scientific recommendations are available.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or bioequivalence (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 product-specific guidances 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 Questions regarding submission of datasets to CDER may be sent to

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 the website ( 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 Help Desk at 1-877-378-5457 (toll free) for assistance regarding submissions.

The FDA posts plans for issuing new or revised product-specific guidances on the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page.

For additional information on development of generic drug products, please refer to FDA’s biopharmaceutics guidances.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter)




Total number of currently published PSGs: 1921

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

111 record(s) found for 'B'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Bacitracin ointment_RLD61212_RV09-16.pdf Draft Ophthalmic Ointment 061212 10/2016
Baclofen Draft Oral Tablet, Orally Disintegrating 021589 11/2019
Baclofen Draft Oral Tablet 017851 02/2010
Baloxavir Marboxil Draft Oral Tablet 210854 09/2019
Balsalazide Disodium Draft Oral Tablet 022205 06/2013
Balsalazide Disodium Draft Oral Capsule 020610 01/2008
Baricitinib Draft Oral Tablets 207924 09/2019
Barium Sulfate sulfate_oral paste_NDA 208844_RC08-17.pdf Draft Oral Paste 208844 10/2017
Barium Sulfate sulfate_oral supension_NDA 208036_RC11-17.pdf Draft Oral Suspension 208036 02/2018
Barium Sulfate sulfate_oral supension_NDA 208143_RC11-17.pdf Draft Oral Suspension 208143 02/2018
Beclomethasone Dipropionate dipropionate_draft_Nasal aerosol metered_RLD 202813_RC07-18.pdf Draft Nasal Aerosol, Metered 202813 07/2018
Beclomethasone Dipropionate Draft Inhalation Aerosol, Metered 020911 03/2020
Beclomethasone Dipropionate dipropionate Inhalation Aerosol Metered NDA 207921 PSG Page RC May 2019.pdf Draft Inhalation Aerosol, Metered 207921 05/2019
Bedaquiline Fumarate Draft Oral Tablet 204384 11/2013
Benazepril Hydrochloride Draft Oral Tablet 019851 07/2010
Benazepril Hydrochloride; Hydrochlorothiazide HCL and hydrochlorothiazide_oral tablet_20033_RC09-15.pdf Draft Oral Tablet 020033 09/2015
Benoxinate hydrochloride; Fluorescein sodium hydrochloride; Fluorescein sodium Ophthalmic solution drops 0.25-0.45 NDA 208582 PSG Page RC May 2019.pdf Draft Topical Solution, Drops 208582 05/2019
Benznidazole Oral Tablets NDA 209570 RC 09-2018.pdf Draft Oral Tablet 209570 09/2018
Benzonatate _oral capsule_040749 040627 201209_RV09-15.pdf Draft Oral Capsule 011210 09/2015
Benzoyl Peroxide; Clindamycin Phosphate Draft Topical Gel 050819 11/2019
Benzoyl Peroxide; Clindamycin Phosphate Draft Topical Gel 050741 11/2019
Benzoyl Peroxide; Clindamycin Phosphate Draft Topical Gel 050756 11/2019
Benzoyl Peroxide; Erythromycin Draft Topical Gel 050557 11/2019
Benzoyl Peroxide; Erythromycin Draft Topical Gel 050769 11/2019
Benzphetamine Hydrochloride Final Oral Tablet 012427 05/2008
Benztropine Mesylate Draft Oral Tablet 009193 09/2019
Benzyl Alcohol Draft Topical Lotion 022129 12/2014
Besifloxacin Hydrochloride Draft Ophthalmic Suspension/Drops 022308 03/2020
Betamethasone Acetate; Betamethasone Sodium Phosphate;_Sodium_Phosphate_Inj_14602_RC04-10.pdf Draft Injection Suspension, Injectable 014602 04/2010
Betamethasone dipropionate dipropionate_topical Lotion_NDA 01778_RC08-17.pdf Draft Topical Lotion 017781 10/2017
Betamethasone dipropionate Dipropionate_topical cream 0.05_RLD 019137_RC09-16.pdf Draft Topical Cream 019137 10/2016
Betamethasone dipropionate dipropionate_ topical augmented cream_RLD 19555_RC04-16.pdf Draft Topical Cream, Augmented 019555 04/2016
Betamethasone dipropionate dipropionate_topical augmented lotion_RLD 019716_RC01-16.pdf Draft Topical Lotion, Augmented 019716 01/2016
Betamethasone dipropionate dipropionate_topical augmented ointment_NDA 018741_RC11-17.pdf Draft Topical Ointment, Augmented 018741 02/2018
Betamethasone dipropionate dipropionate_draft_Topical spray_RLD 208079_RC07-18.pdf Draft Topical Spray 208079 07/2018
Betamethasone Dipropionate; Calcipotriene Draft Topical Aerosol, Foam 207589 11/2019
Betamethasone Dipropionate; Calcipotriene; Calcipotriene Ointment NDA 021852 RV Feb 2019.pdf Draft Topical Ointment 021852 02/2019
Betamethasone Dipropionate; Calcipotriene; Calcipotriene Suspension NDA 022185 RV Feb 2019.pdf Draft Topical Suspension 022185 02/2019
Betamethasone dipropionate;Clotrimazole Dipropionate; Clotrimazole Lotion NDA 020010 RV Feb 2019.pdf Draft Topical Lotion 020010 02/2019
Betamethasone dipropionate;Clotrimazole Dipropionate; Clotrimazole Cream NDA 018827 RV Feb 2019.pdf Draft Topical Cream 018827 02/2019
Betamethasone Valerate valerate_topical cream_RLD 018861_RC12-16.pdf Draft Topical Cream 018861 12/2016
Betamethasone Valerate valerate_topical ointment_RLD 18865_RC10-16.pdf Draft Topical Ointment 018865 10/2016
Betamethasone Valerate Draft Topical Aerosol, Foam 020934 12/2014
Betamethasone Valerate valerate_topical lotion_RLD 018866_RC01-16.pdf Draft Topical Lotion 018866 01/2016
Betaxolol Hydrochloride HYDROCHLORIDE ophthalmic suspensiondrops NDA 019845 PSG Page RV May 2019.pdf Draft Ophthalmic Suspension, Drops 019845 05/2019
Bethanechol Chloride Draft Oral Tablet 006536 09/2008
Betrixaban cap_RLD 208383_RC07-18.pdf Draft Oral Capsule 208383 07/2018
Bexarotene topical gel NDA 021056 RC 2019.pdf Draft Topical Gel 021056 02/2019
Bexarotene Draft Oral Capsule 021055 08/2021
Bicalutamide Final Oral Tablet 020498 05/2008
Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate Sodium, Emtricitabin, Tenofovir Alafenamide Fumarate Oral Tablet NDA 210251 page RC May 2019.pdf Draft Oral Tablet 210251 05/2019
Bimatoprost solution drops_NDA 021275_RC11-17.pdf Draft Ophthalmic Solution, Drops 021275 02/2018
Bimatoprost solution drops_NDA 022184_RC11-17.pdf Draft Ophthalmic Solution, Drops 022184 02/2018
Bimatoprost solution drops_NDA 022369_RC11-17.pdf Draft Topical Solution, Drops 022369 02/2018
Binimetinib Draft Oral Tablet 210498 03/2020
Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; PEG3350_ANDA 202217_RC03-17.pdf Draft Oral For Solution, Tablet, Delayed Release 021551 05/2017
Bismuth Subcitrate Potassium; Metronidazole;Tetracycline Hydrochloride Draft Oral Capsule 050786 09/2008
Bisoprolol Fumarate Final Oral Tablet 019982 05/2008
Bisoprolol Fumarate; Hydrochlorothiazide Final Oral Tablet 020186 05/2008
Boceprevir Draft Oral Capsule 202258 06/2012
Bortezomib Draft Intravenous, Subcutaneous Injectable 021602 08/2020
Bosentan Tablets for oral suspension NDA 209279 RC Feb 2019.pdf Draft Oral Tablet, For Suspension 209279 02/2019
Bosentan Draft Oral Tablet 021290 03/2012
Bosutinib Monohydrate Draft Oral Tablet 203341 09/2019
Bremelanotide Acetate Draft Subcutaneous Solution 210557 03/2021
Brexanolone Draft Intravenous Solution 211371 06/2020
Brexpiprazole tablet_NDA 205422_RC05-17.pdf Draft Oral Tablet 205422 07/2017
Brigatinib tab_RLD 208772_RC09-18.pdf Draft Oral Tablet 208772 09/2018
Brimonidine Tartrate tartrate ophthalmic solution 0.025 NDA 208144 PSG Page RC May 2019.pdf Draft Ophthalmic Drops, Solution 208144 05/2019
Brimonidine Tartrate tartrate_ophthalmic solution_NDA 021770_RV08-17.pdf Draft Ophthalmic Solution, Drops 0.1% 021770 10/2017
Brimonidine Tartrate tartrate_ophthalmic solution_NDA 020613_RV08-17.pdf Draft Ophthalmic Solution, Drops 0.2% 020613 10/2017
Brimonidine Tartrate tartrate_topical gel_204708_RC09-15.pdf Draft Topical Gel 204708 09/2015
Brimonidine Tartrate Tartrate_Ophthalmic Solution_NDA 021262_RV07-17.pdf Draft Ophthalmic Solution, Drops 0.15% 021262 07/2017
Brimonidine Tartrate; Brinzolamide TARTRATE BRINZOLAMIDE ophthalmic suspension drops NDA 204251 PSG Page RV May 2019.pdf Draft Ophthalmic Drops, Suspension 204251 05/2019
Brimonidine Tartrate;Timolol Maleate tartrate Timolol MaleateNDA 021398 RC 09-2018.pdf Draft Ophthalmic Solution, Drops 021398 09/2018
Brinzolamide ophthalmic suspension drops NDA 020816 PSG Page RV May 2019.pdf Draft Ophthalmic Suspension, Drops 1% 020816 05/2019
Brivaracetam tablet_NDA 205836_RC05-17.pdf Draft Oral Tablet 205836 07/2017
Bromfenac Sodium sodium_ophthalmic solution_NDA 021664_RV08-17.pdf Draft Ophthalmic Solution, Drops 021664 10/2017
Bromocriptine Mesylate Mesylate_cap_17962_RC11-09.pdf Draft Oral Capsule 017962 11/2009
Bromocriptine Mesylate Mesylate_tab_17962_RC11-09.pdf Draft Oral Tablet 017962 11/2009
Bromocriptine mesylate Mesylate Tablets NDA20866 RC Feb 2019.pdf Draft Oral Tablet 020866 02/2019
Budesonide Draft Rectal Aerosol, Foam 205613 11/2020
Budesonide Draft Nasal Spray, Metered 020746 08/2020
Budesonide Draft Oral Capsule, Extended Release 211929 03/2020
Budesonide Draft Oral Capsule, Delayed Release 021324 08/2021
Budesonide powder_RLD 21949_RC12-16.pdf Draft Inhalation Powder 021949 12/2016
Budesonide Draft Inhalation Suspension 020929 09/2012
Budesonide Draft Oral Tablet, Extended Release 203634 12/2014
Budesonide; Formoterol Fumarate Dihydrate and Formoterol fumarate dihydrate_MDI_021929_RC06-15.pdf Draft Inhalation Aerosol, Metered 021929 06/2015
Bumetanide Draft Oral Tablet 018225 11/2013
Bupivacaine liposomal injectable injection_NDA 022496_RC11-17.pdf Draft Injection Injectable, Liposomal 022496 02/2018
Buprenorphine Draft Transdermal Film, Extended Release 021306 06/2020
Buprenorphine Draft Subcutaneous Solution, Extended Release 209819 06/2020
Buprenorphine Hydrochloride Draft Sublingual Tablet 020732 02/2014
Buprenorphine Hydrochloride hydrochloride_buccal film_NDA 207932_RC11-17.pdf Draft Buccal Film 207932 02/2018
Buprenorphine Hydrochloride; Naloxone Hydrochloride HCL_Naloxone HCL_Buccal Film_205637_RC03-15.pdf Draft Buccal Film 205637 03/2015
Buprenorphine Hydrochloride; Naloxone Hydrochloride HCL; Naloxone HCL_sublingual buccal film_RLD 022410_RV12-16.pdf Draft Buccal, Sublingual Film 022410 12/2016
Buprenorphine Hydrochloride; Naloxone Hydrochloride;_Naloxone_HCl_subtab_20733_RC5-10.pdf Draft Sublingual Tablet 020733 05/2010
Buprenorphine Hydrochloride; Naloxone Hydrochloride Hcl; Naloxone Hcl_sublingual tablet_RLD 204242_RV12-16.pdf Draft Sublingual Tablet 204242 12/2016
Bupropion Hydrobromide Draft Oral Tablet, Extended Release 022108 03/2013
Bupropion Hydrochloride Draft Oral Tablet, Extended Release 022497 03/2013
Bupropion Hydrochloride Draft Oral Tablet 018644 03/2013
Bupropion Hydrochloride Draft Oral Tablet, Extended Release 021515 03/2013
Bupropion Hydrochloride Draft Oral Tablet, Extended Release 020358 020711 03/2013
Bupropion Hydrochloride; Naltrexone Hydrochloride Draft Oral Tablet, Extended Release 200063 11/2020
Buspirone Hydrochloride Draft Oral Tablet 018731 12/2009
Busulfan Draft Oral Tablet 009386 07/2009
Butenafine Hydrochloride HCl Cream NDA 20524 RV Feb 2019.pdf Draft Topical Cream 020524 02/2019
Butenafine Hydrochloride HCl Cream NDA 021307 RV Feb 2019.pdf Draft Topical Cream 021307 02/2019
Butoconazole Nitrate Nitrate Vaginal Cream ANDA 200923 RV Feb 2019.pdf Draft Vaginal Cream 200923 02/2019
Butoconazole Nitrate Nitrate Vaginal Cream NDA 020421 RV Feb 2019.pdf Draft Vaginal Cream 020421 02/2019

Newly Added Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acyclovir Draft Ophthalmic Ointment 202408 08/2021
Albuterol Sulfate; Ipratropium Bromide Draft Inhalation Spray, Metered 021747 08/2021
Amisulpride Draft Intravenous Solution 209510 08/2021
Avapritinib Draft Oral Tablet 212608 08/2021
Carbinoxamine Maleate Draft Oral Tablet 008915 08/2021
Cefiderocol Sulfate Tosylate Draft Intravenous Powder 209445 08/2021
Copper Dotatate Cu-64 Draft Intravenous Solution 213227 08/2021
Esomeprazole Magnesium Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Estradiol Draft Transdermal Gel, Metered 021166 08/2021
Ethinyl Estradiol; Levonorgestrel Draft Transdermal System 204017 08/2021
Fostemsavir Tromethamine Draft Oral Tablet, Extended Release 212950 08/2021
Indomethacin Draft Rectal Suppository 017814 08/2021
Ipratropium Bromide Draft Nasal Spray, Metered 020393 020394 08/2021
Lasmiditan Succinate Draft Oral Tablet 211280 08/2021
Leuprolide Acetate Draft Subcutaneous Powder 021343 08/2021
Loteprednol Etabonate Draft Ophthalmic Gel 208219 08/2021
Olodaterol Hydrochloride Draft Inhalation Spray, Metered 203108 08/2021
Osilodrostat Phosphate Draft Oral Tablet 212801 08/2021
Ozanimod Hydrochloride Draft Oral Capsule 209899 08/2021
Paliperidone Palmitate Draft Intramuscular Suspension, Extended Release 207946 08/2021
Semaglutide Draft Oral Tablet 213051 08/2021
Sufentanil Citrate Draft Sublingual Tablet 209128 08/2021
Tazemetostat Hydrobromide Draft Oral Tablet 211723 08/2021

Newly Revised Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Bexarotene Draft Oral Capsule 021055 08/2021
Budesonide Draft Oral Capsule, Delayed Release 021324 08/2021
Eltrombopag Olamine Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine Draft Oral For Suspension 207027 08/2021
Ferric Citrate Draft Oral Tablet 205874 08/2021
Ferric Oxyhydroxide Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide Draft Intravenous Injectable 021135 09/2021
Letrozole Draft Oral Tablet 020726 08/2021
Leuprolide Acetate Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate Draft Injection Injectable 020517 020708 08/2021
Liothyronine Sodium Draft Oral Tablet 010379 08/2021
Loteprednol Etabonate Draft Ophthalmic Suspension/Drops 020583 08/2021
Nystatin Draft Topical Powder 065203 08/2021
Orlistat Draft Oral Capsule 020766 021887 08/2021
Paclitaxel Draft IV Infusion For Suspension 021660 08/2021
Podofilox Draft Topical Gel 020529 08/2021
Sodium Zirconium Cyclosilicate Draft Oral For Suspension 207078 08/2021
Tazarotene Draft Topical Cream 0.05% 021184 08/2021

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