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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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

43 record(s) found for 'G'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Gabapentin tablet_22544_RV09-15.pdf Draft Oral Tablet 022544 09/2015
Gabapentin Draft Oral Capsule 020235 05/2007
Gabapentin Final Oral Tablet 020882 05/2008
Gabapentin Enacarbil Draft Oral Tablet, Extended Release 022399 06/2012
Galantamine Hydrobromide Draft Oral Tablet 021169 11/2010
Galantamine Hydrobromide Draft Oral Capsule, Extended Release 021615 05/2007
Gallium DOTATOC Ga 68 Draft Intravenous Solution 210828 08/2020
Ganciclovir cap 19661 RC5-03.pdf Draft Oral Capsule 020460 08/2007
Gatifloxacin solution drops_NDA 021493_RV11-17.pdf Draft Ophthalmic Solution 0.3% 021493 02/2018
Gefitinib tablet_NDA 206995_RV05-17.pdf Draft Oral Tablet 206995 07/2017
Gemfibrozil tab_18422_RC12-09.pdf Draft Oral Tablet 018422 12/2009
Gemifloxacin Mesylate Final Oral Tablet 021158 05/2008
Gentamicin Sulfate sulfate_topical cream_ANDA 062307_RC05-17.pdf Draft Topical Cream 062307 07/2017
Gentamicin Sulfate sulfate_topical ointment_ANDA 062351_RC 03-17.pdf Draft Topical Ointment 062351 05/2017
Gentamicin Sulfate sulfate_ophthalmic solution drops_NDA 050039_RV11-17.pdf Draft Ophthalmic Solution 050039 02/2018
Gilteritinib Fumarate Draft Oral Tablet 211349 06/2020
Glasdegib Maleate Draft Oral Tablet 210656 08/2020
Glatiramer Acetate acetate_subcutaneous Injection_NDA 020622_RV07-18.pdf Draft Subcutaneous Injection 020622 07/2018
Glecaprevir; Pibrentasvir Pibrentasvir Oral Tablet NDA 209394 RC 09-2018.pdf Draft Oral Tablet 209394 09/2018
Glimepiride Final Oral Tablet 020496 05/2008
Glimepiride; Pioglitazone Hydrochloride;_Pioglitazone_tab_21925_RC5-09.pdf Final Oral Tablet 021925 10/2011
Glimepiride; Rosiglitazone Maleate Draft Oral Tablet 021700 11/2007
Glipizide Draft Oral Tablet 017783 08/2010
Glipizide Draft Oral Tablet, Extended Release 020329 07/2008
Glipizide; Metformin Hydrochloride Final Oral Tablet 021460 05/2008
Glyburide Draft Oral Tablet 020051 03/2012
Glyburide Draft Oral Tablet 017532 074388 03/2012
Glyburide; Metformin Hydrochloride Draft Oral Tablet 021178 12/2009
Glycopyrrolate Powder_NDA 207923_RC05-17.pdf Draft Inhalation Powder 207923 07/2017
Glycopyrrolate Draft Oral Tablet 012827 11/2009
Glycopyrrolate; Indacaterol Maleate Draft Inhalation Powder 207930 06/2020
Glycopyrronium Tosylate Draft Topical Cloth 210361 09/2019
Goserelin Acetate Draft Subcutaneous Implant 019726 020578 10/2008
Granisetron Draft Transdermal Film, Extended Release 022198 11/2019
Granisetron Draft Subcutaneous Injection, Extended Release 022445 03/2020
Granisetron Hydrochloride Draft Oral Tablet 020305 08/2010
Griseofulvin Microsize Draft Oral Suspension 062483 11/2010
Griseofulvin Ultramicrosize,_Ultramicrocrystalline_tab_50475_RC10-08.pdf Draft Oral Tablet 050475 10/2008
Griseofulvin; Microcrystalline Draft Oral Tablet 062279 02/2010
Guaifenesin Draft Oral Tablet, Extended Release 021282 04/2014
Guaifenesin; Pseudoephedrine Hydrochloride;_Pseudoephedrine_HCl_ERtab_21585_RC12-08.pdf Draft Oral Tablet, Extended Release 021585 12/2008
Guanfacine Hydrochloride hydrochloride_oral ER tablet_022037_RV01-16.pdf Draft Oral Tablet, Extended Release 022037 01/2016
Guanfacine Hydrochloride Draft Oral Tablet 019032 03/2021

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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