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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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

106 record(s) found for 'F'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Famciclovir Draft Oral Tablet 020363 08/2008
Famotidine Draft Oral Suspension 019527 12/2008
Famotidine Final Oral Tablet, Orally Disintegrating 021712 05/2008
Famotidine Final Oral Tablet 019462 020325 05/2008
Famotidine; Ibuprofen; Ibuprofen_Tab_22519_RC06-12.pdf Draft Oral Tablet 022519 06/2012
Febuxostat Draft Oral Tablet 021856 02/2010
Fedratinib Hydrochloride Draft Oral Capsule 212327 03/2021
Felbamate suspension_NDA 020189_RV11-17.pdf Draft Oral Suspension 020189 02/2018
Felbamate tablet_NDA 020189_RV11-17.pdf Draft Oral Tablet 020189 02/2018
Felodipine Draft Oral Tablet, Extended Release 019834 12/2009
Fenofibrate capsule_RLD 021695 (90 and 30 mg)_RC12-16.pdf Draft Oral Capsule 021695 12/2016
Fenofibrate Draft Oral Tablet 021203 03/2012
Fenofibrate Draft Oral Capsule 019304 02/2010
Fenofibrate Draft Oral Tablet 022118 09/2008
Fenofibrate Draft Oral Capsule 021612 02/2008
Fenofibrate Final Oral Capsule 021695 05/2008
Fenofibrate Final Oral Tablet 021656 05/2008
Fenofibrate Draft Oral Tablet 021350 10/2008
Fenofibric Acid Draft Oral Tablet 022418 08/2010
Fenoprofen Calcium Draft Oral Capsule 017604 03/2021
Fentanyl spray_202788_RC06-15.pdf Draft Sublingual Spray 202788 06/2015
Fentanyl Draft Transdermal Film, Extended Release 019813 11/2019
Fentanyl Citrate Draft Nasal Spray, Metered 022569 04/2014
Fentanyl Citrate Draft Sublingual Tablet 022510 09/2012
Fentanyl Citrate Draft Transmucosal Troche/Lozenge 020747 02/2010
Fentanyl Citrate Draft Buccal, Sublingual Tablet 021947 06/2013
Ferric Carboxymaltose CARBOXYMALTOSE_injection_RLD 203565_RC04-16.pdf Draft Intravenous Injectable 203565 04/2016
Ferric Citrate Draft Oral Tablet 205874 08/2021
Ferric Maltol Draft Oral Capsule 212320 03/2021
Ferric Oxyhydroxide Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide Draft Intravenous Injectable 021135 09/2021
Ferumoxytol Draft Intravenous Injection 022180 12/2012
Fesoterodine Fumarate Draft Oral Tablet, Extended Release 022030 11/2010
Fexofenadine Hydrochloride Draft Oral Suspension 021963 12/2008
Fexofenadine Hydrochloride Draft Oral Tablet, Orally Disintegrating 021909 08/2008
Fexofenadine Hydrochloride Draft Oral Capsule 020625 07/2009
Fexofenadine Hydrochloride Draft Oral Tablet 020872 09/2008
Fexofenadine Hydrochloride Draft Oral Suspension 201373 09/2019
Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride;_Pseudoephedrine_ERtab_20786_21704_RC10-09.pdf Draft Oral Tablet, Extended Release 020786 021704 10/2009
Fidaxomicin tablet_RLD 201699_RC08-16 separate posting.pdf Draft Oral Tablet 201699 08/2016
Finafloxacin suspension drops_NDA 206307_RC07-18.pdf Draft Otic Suspension, Drops 206307 07/2018
Finasteride Draft Oral Tablet 020180 020788 01/2011
Fingolimod Hydrochloride Draft Oral Capsule 022527 09/2019
Fish Oil Triglycerides Draft Intravenous Emulsion 210589 06/2020
Fish oil; Medium chain triglycerides; Olive oil; Soybean oil oil; Medium chain triglycerides; Olive oil; Soybean oil NDA 207648 Feb 2019.pdf Draft Intravenous Emulsion 207648 02/2019
Flavoxate Hydrochloride Draft Oral Tablet 016769 11/2019
Flecainide Acetate Draft Oral Tablet 018830 02/2010
Flibanserin tablet_RLD 22526_RC06-16.pdf Draft Oral Tablet 022526 06/2016
Fluconazole tablet_NDA 019949_RV11-17.pdf Draft Oral Tablet 019949 02/2018
Flucytosine Draft Oral Capsule 017001 07/2010
Fludarabine Phosphate Draft Oral Tablet 022273 03/2012
Fludrocortisone Acetate Final Oral Tablet 010060 10/2011
Fluocinolone acetonide acetonide_topical cream_NDA 012787_RC07-18.pdf Draft Topical Cream 012787 07/2018
Fluocinolone Acetonide; Hydroquinone; Tretinoin Draft Topical Cream 021112 03/2015
Fluocinonide cream_RLD 21758_RC12-16.pdf Draft Topical Cream 021758 12/2016
Fluocinonide gel_RLD 074935_RC06-16.pdf Draft Topical Gel 017373 06/2016
Fluocinonide ointment_RLD 075008_RC 06-16.pdf Draft Topical Ointment 016909 06/2016
Fluocinonide cream_NDA 019117_RC11-17.pdf Draft Topical Cream 019117 02/2018
Fluorodopa F-18 Draft Intravenous Solution 200655 11/2020
Fluorometholone Draft Ophthalmic Suspension/Drops 019216 06/2020
Fluorometholone suspension_NDA 016851_RC08-17.pdf Draft Ophthalmic Drops, Suspension 016851 10/2017
Fluorometholone Acetate Draft Ophthalmic Suspension, Drops 019079 09/2019
Fluorouracil Topical Cream NDA 016988 RV Feb 2019.pdf Draft Topical Cream 016988 02/2019
Fluorouracil Draft Topical Solution 5% 016831 06/2011
Fluorouracil Draft Topical Solution 2% 016831 06/2011
Fluorouracil Topical Cream NDA 020985 RV Feb 2019.pdf Draft Topical Cream 020985 02/2019
Fluorouracil Topical Cream NDA 016831 RV Feb 2019.pdf Draft Topical Cream 016831 02/2019
Fluoxetine Hydrochloride hcl_oral tablet_RLD 202133_RC12-16.pdf Draft Oral Tablet 202133 12/2016
Fluoxetine Hydrochloride Draft Oral Tablet 021860 02/2011
Fluoxetine Hydrochloride Draft Oral Tablet 020974 02/2011
Fluoxetine Hydrochloride Draft Oral Capsule, Delayed Release 021235 08/2010
Fluoxetine Hydrochloride Draft Oral Capsule 018936 06/2013
Fluoxetine Hydrochloride; Olanzapine Draft Oral Capsule 021520 07/2009
Fluphenazine Hydrochloride Draft Oral Tablet 011751 089743 11/2020
Flurandrenolide lotion_RLD 013790_RC01-16.pdf Draft Topical Lotion 013790 01/2016
Flutamide Draft Oral Capsule 018554 04/2013
Fluticasone Furoate furoate_inhalation powder_RLD 205625_RC04-16.pdf Draft Inhalation Powder 205625 04/2016
Fluticasone Furoate Draft Nasal Spray, Metered 022051 06/2020
Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate Draft Inhalation Powder 209482 05/2021
Fluticasone Furoate; Vilanterol Trifenatate furoate; Vilanterol trif_inhal_ pow_204275_RC04-16.pdf Draft Inhalation Powder 204275 04/2016
Fluticasone Propionate propionate metered inhalation aerosol NDA 021433 RV 07-2018.pdf Draft Inhalation Aerosol, Metered 021433 07/2018
Fluticasone Propionate proprionate_inhalation powder_NDA 020833_RC10-17.pdf Draft Inhalation Powder 020833 10/2017
Fluticasone Propionate propionate_topical ointment_RLD 19957_RC09-16.pdf Draft Topical Ointment 019957 10/2016
Fluticasone Propionate Draft Topical Cream 019958 02/2011
Fluticasone Propionate Draft Nasal Spray, Metered 205434 05/2021
Fluticasone Propionate Draft Nasal Spray, Metered 020121 06/2020
Fluticasone Propionate Propionate Inhalation Powder NDA 208798 PSG Page RC May 2019.pdf Draft Inhalation Powder 208798 05/2019
Fluticasone Propionate; Salmeterol Xinafoate Draft Inhalation Aerosol, Metered 021254 06/2020
Fluticasone Propionate; Salmeterol Xinafoate Draft Inhalation Powder 208799 09/2019
Fluticasone Propionate; Salmeterol Xinafoate Proprionate_Salmeterol Xinafoate_21077_RC09-13.pdf Draft Inhalation Powder 021077 09/2013
Fluvastatin Sodium Draft Oral Capsule 020261 01/2008
Fluvastatin Sodium Draft Oral Tablet, Extended Release 021192 01/2008
Fluvoxamine Maleate Draft Oral Capsule, Extended Release 022033 02/2011
Formoterol Fumarate fumarate_Inhalation powder_020831_RC09-15.pdf Draft Inhalation Powder 020831 09/2015
Formoterol Fumarate; Mometasone Furoate fumarate_Mometasone furoate_inhalation aerosol_RLD 022518_RC01-16.pdf Draft Inhalation Aerosol, Metered 022518 01/2016
Fosamprenavir Calcium Draft Oral Suspension 022116 11/2007
Fosamprenavir Calcium Final Oral Tablet 021548 05/2008
Fosfomycin Tromethamine Tromethamine Oral Solution NDA 050717 PSG Page RV May 2019.pdf Draft Oral For Solution 050717 05/2019
Fosinopril Sodium Draft Oral Tablet 019915 05/2008
Fosinopril Sodium; Hydrochlorothiazide Draft Oral Tablet 020286 09/2008
Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride and Palonosetron Hydrochloride, powder for injection NDA 210493 PSG Page RC May 2019.pdf Draft Intravenous Powder 210493 05/2019
Fostamatinib Disodium Draft Oral Tablet 209299 09/2019
Fostemsavir Tromethamine Draft Oral Tablet, Extended Release 212950 08/2021
Frovatriptan Succinate Draft Oral Tablet 021006 10/2008
Fulvestrant Draft Injection, Intramuscular Solution 021344 03/2012
Furosemide Draft Oral Tablet 016273 09/2010

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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