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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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

79 record(s) found for 'S'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Sacubitril; Valsartan; Valsartan_oral tablet_RLD 207620_RC04-16.pdf Draft Oral Tablet 207620 04/2016
Safinamide Mesylate mesylate_oral tablet_NDA 207145_RC11-17.pdf Draft Oral Tablet 207145 02/2018
Salmeterol Xinafoate xinafoate_inhalation powder_NDA 020692_RC10-17.pdf Draft Inhalation Powder 020692 10/2017
Sapropterin Dihydrochloride dihydrochloride_tab_022181_RC09-12.pdf Draft Oral Tablet 022181 09/2012
Saquinavir Mesylate Draft Oral Capsule 020628 11/2007
Saquinavir Mesylate Draft Oral Tablet 021785 11/2007
Sarecycline Hydrochloride Draft Oral Tablet 209521 09/2019
Saxagliptin Hydrochloride Draft Oral Tablet 022350 09/2012
Scopolamine Draft Transdermal Film, Extended Release 017874 11/2019
Secnidazole Oral Granules NDA 209363 RC 09-2018.pdf Draft Oral Granules 209363 09/2018
Selegiline Draft Transdermal Film, Extended Release 021336 11/2019
Selegiline Hydrochloride Draft Oral Tablet, Orally Disintegrating 021479 09/2008
Selegiline Hydrochloride HCl_oral capsule_RLD 20647_Final 08-17.pdf Final Oral Capsule 020647 08/2017
Selenious Acid Draft Intravenous Solution 209379 03/2020
Selexipag Draft Oral Tablet 207947 03/2020
Selinexor Draft Oral Tablet 212306 03/2021
Semaglutide Draft Subcutaneous Solution 209637 03/2020
Semaglutide Draft Oral Tablet 213051 08/2021
Sertraline Hydrochloride Final Oral Tablet 019839 05/2008
Sevelamer Carbonate Draft Oral Suspension 022318 12/2014
Sevelamer Carbonate carbonate_oral tablet_022127_RV09-15.pdf Draft Oral Tablet 022127 09/2015
Sevelamer Hydrochloride Draft Oral Tablet 021179 12/2014
Sibutramine Hydrochloride Final Oral Capsule 020632 05/2008
Sildenafil Citrate citrate_oral suspension_203109_RC06-15.pdf Draft Oral Suspension 203109 06/2015
Sildenafil Citrate Draft Oral Tablet 020895 021845 12/2008
Silodosin Draft Oral Capsule 022206 04/2013
Silver Sulfadiazine sulfadiazine_topical cream_NDA 017381_RC05-17.pdf Draft Topical Cream 017381 07/2017
Simeprevir Sodium sodium_Oral capsule_205123_RC06-15.pdf Draft Oral Capsule 205123 06/2015
Simvastatin suspension_RLD 206679_RC12-16.pdf Draft Oral Suspension 206679 12/2016
Simvastatin Final Oral Tablet 019766 05/2008
Simvastatin Draft Oral Tablet, Orally Disintegrating 021961 08/2008
Simvastatin; Sitagliptin Phosphate; Sitagliptin phosphate_oral tablet_NDA 202343_RC11-17.pdf Draft Oral Tablet 202343 02/2018
Siponimod Fumaric Acid Draft Oral Tablet 209884 03/2021
Sirolimus tablet_021110_RV09-15.pdf Draft Oral Tablet 021110 09/2015
Sitagliptin Phosphate Draft Oral Tablet 021995 07/2010
Sodium Ferric Gluconate Complex Draft Injectable Injection 020955 06/2013
Sodium Iodide I123 Draft Oral Capsule 018671 07/2008
Sodium Phenylbutyrate Draft Oral Powder 020573 05/2009
Sodium Phenylbutyrate Draft Oral Tablet 020572 05/2009
Sodium Phosphate Dibasic Anhydrous; Sodium Phosphate Monobasic Monohydrate Draft Oral Tablet 021892 12/2012
Sodium Polystyrene Sulfonate Draft Oral/Rectal Powder 011287 03/2015
Sodium Polystyrene Sulfonate Draft Oral, Rectal Suspension 087859 08/2020
Sodium Zirconium Cyclosilicate Draft Oral For Suspension 207078 08/2021
Sofosbuvir Draft Oral Pellets 212480 03/2021
Sofosbuvir Draft Oral Tablet 204671 05/2021
Sofosbuvir; Velpatasvir; velpatasir_oral tablet_RLD 208341_RC03-17.pdf Draft Oral Tablet 208341 05/2017
Sofosbuvir; Velpatasvir; Voxilaprevir Velpatasvir Voxilaprevir Oral Tablets NDA 209195 RC 09-2018.pdf Draft Oral Tablet 209195 09/2018
Solifenacin Succinate Draft Oral Tablet 021518 02/2008
Solriamfetol Hydrochloride Draft Oral Tablet 211230 03/2021
Sonidegib Phosphate phosphate_oral capsule_RLD 205266_RC04-16.pdf Draft Oral Capsule 205266 04/2016
Sorafenib Tosylate Draft Oral Tablet 021923 06/2012
Sotalol Hydrochloride Draft Oral Tablet 019865 12/2010
Sotalol Hydrochloride HCl_oral tablet_ RLD 21151_Final 08-17.pdf Final Oral Tablet 021151 08/2017
Soybean Oil oil_injectable injection_NDA 019531_RC11-17.pdf Draft Injectable Injection 019531 02/2018
Soybean Oil oil_injectable injection_NDA 020248, 018449, 017643_RC11-17.pdf Draft Injectable Injection 017643 018449 020248 02/2018
Spinosad suspension_RLD 022408_RC01-16.pdf Draft Topical Suspension 022408 01/2016
Spironolactone Draft Oral Tablet 012151 12/2009
Spironolactone Suspension Oral NDA 209478 RC 09-2018.pdf Draft Oral Suspension 209478 09/2018
Stavudine Final Oral Capsule 020412 05/2008
Stiripentol Draft Oral Capsule 206709 03/2020
Stiripentol Draft Oral For Suspension 207223 03/2020
Succimer Oral Capsule 100 mg NDA 019998 RC Feb 2019.pdf Draft Oral Capsules 019998 02/2019
Sucralfate Draft Oral Tablet 018333 09/2019
Sucralfate suspension_NDA 019183_RV08-17.pdf Draft Oral Suspension 019183 10/2017
Sufentanil Citrate Draft Sublingual Tablet 209128 08/2021
Sulfacetamide Sodium Draft Topical Lotion 019931 11/2019
Sulfadiazine Draft Oral Tablet 040091 11/2019
Sulfamethoxazole; Trimethoprim; Trimethoprim_oral tablet_NDA 017377_RV11-17.pdf Draft Oral Tablet 017377 02/2018
Sulfamethoxazole;Trimethoprim Trimethoprim_Oral suspesion_NDA 017560_RV Oct 2018.pdf Draft Oral Suspension 077612 11/2018
Sulfasalazine Draft Oral Tablet, Delayed Release 007073 02/2010
Sulfasalazine Draft Oral Tablet 007073 02/2010
Sulfur Hexafluoride Lipid Type A Microspheres hexafluoridelipid Type-A microspheresuspension 203684RC 09-2018.pdf Draft Intravenous Suspension 203684 09/2018
Sumatriptan spray_NDA 020626_RV Nov 2018.pdf Draft Nasal Spray 020626 11/2018
Sumatriptan Draft Nasal Spray 210884 08/2020
Sumatriptan Succinate Draft Nasal Powder 206099 03/2020
Sumatriptan Succinate Final Oral Tablet 020132 05/2008
Sumatriptan Succinate Draft Subcutaneous Injectable 020080 11/2019
Sunitinib Malate Draft Oral Capsule 021938 04/2010
Suvorexant tablet_204569_RC09-15.pdf Draft Oral Tablet 204569 09/2015

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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