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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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

142 record(s) found for 'T'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Tacrolimus ER tablet_RLD 206406_RC06-16.pdf Draft Oral Tablet, Extended Release 206406 06/2016
Tacrolimus topical ointment 0.1 NDA 050777 PSG Page RV 09_2018.pdf Draft Topical Ointment 0.1% 050777 09/2018
Tacrolimus for Tacrolimus Ointment 0.03 2018-09-13.pdf Draft Topical Ointment 0.03% 050777 09/2018
Tacrolimus Draft Oral Capsule, Extended Release 204096 07/2014
Tacrolimus Draft Oral Capsule 050708 12/2012
Tacrolimus Draft Oral For Suspension 210115 03/2020
Tadalafil tablet_NDA 022332 and NDA 21368_RV08-17.pdf Draft Oral Tablet 021368 022332 10/2017
Tafamidis Draft Oral Capsule 212161 11/2020
Tafamidis Meglumine Draft Oral Capsule 211996 11/2020
Tafenoquine Succinate Draft Oral Tablet 210795 06/2020
Tafenoquine Succinate Draft Oral Tablet 210607 08/2020
Talazoparib Tosylate Draft Oral Capsule 211651 06/2020
Talc Draft Intrapleural Powder 205555 08/2020
Talc intrapleural aerosol NDA 020587 RC 09-2018.pdf Draft Inhalation Aerosol, Metered 020587 09/2018
Tamoxifen Citrate Final Oral Tablet 017970 10/2011
Tamsulosin Hydrochloride Final Oral Capsule 020579 05/2008
Tapentadol Hydrochloride ERTabs_200533_RC09-10.pdf Draft Oral Tablet, Extended Release 200533 06/2012
Tapentadol Hydrochloride Draft Oral Tablet 022304 11/2010
Tasimelteon capsule_205677_RC09-15.pdf Draft Oral Capsule 205677 09/2015
Tavaborole topical solution NDA 204427 RC 09-2018.pdf Draft Topical Solution 204427 09/2018
Tazarotene Draft Topical Cream 0.05% 021184 08/2021
Tazarotene Draft Topical Aerosol, Foam 202428 11/2019
Tazarotene Draft Topical Gel 0.05% 020600 02/2019
Tazarotene Cream 0.1_NDA 021184 RV Feb 2019.pdf Draft Topical Cream 0.1% 021184 02/2019
Tazarotene Draft Topical Gel 0.1% 020600 11/2019
Tazemetostat Hydrobromide Draft Oral Tablet 211723 08/2021
Tecovirimat Draft Oral Capsule 208627 09/2019
Tedizolid Phosphate phosphate_oral tablet_RLD 205435_RV12-16.pdf Draft Oral Tablet 205435 12/2016
Telaprevir Draft Oral Tablet 201917 09/2012
Telbivudine Final Oral Tablet 022011 10/2011
Telithromycin RC7-06.pdf Final Oral Tablet 021144 05/2008
Telmisartan Draft Oral Tablet 020850 10/2010
Telotristat Etiprate etiprate_oral tablet_NDA 208794_RC08-17.pdf Draft Oral Tablet 208794 10/2017
Temazepam Final Oral Capsule 018163 10/2011
Temozolomide Draft Oral Capsule 021029 07/2009
Tenofovir Alafenamide Fumarate alafenamide fumarate_oral tablet_NDA 208464_RC05-17.pdf Draft Oral Tablet 208464 07/2017
Tenofovir Disoproxil Fumarate Disoproxil Fumarate 022577 RC09-12.pdf Draft Oral Powder 022577 09/2012
Tenofovir Disoproxil Fumarate Disoproxil Fumarate_oral tablet_RLD 21356_Final 08-17.pdf Final Oral Tablet 021356 08/2017
Terazosin Hydrochloride Draft Oral Capsule 020347 11/2019
Terbinafine Hydrochloride Hydrochloride Topical Cream NDA 020980 RV Feb 2019.pdf Draft Topical Cream 020980 02/2019
Terbinafine Hydrochloride Final Oral Granule 022071 10/2011
Terbinafine Hydrochloride Final Oral Tablet 020539 05/2008
Terbutaline Sulfate sulfate_oral tablet_NDA 017849_RC08-17.pdf Draft Oral Tablet 017849 10/2017
Terconazole Draft Vaginal Cream 019579 02/2010
Terconazole Draft Vaginal Cream 019964 02/2010
Terconazole Draft Vaginal Suppository 019641 02/2010
Teriflunomide Draft Oral Tablet 202992 03/2015
Testosterone Draft Transdermal Gel, Metered 1% 021015 11/2013
Testosterone Draft Transdermal Gel, Metered 022309 11/2013
Testosterone mg 0.5 gm gel_21463_RC04-13.pdf Draft Transdermal Gel, Metered 021463 04/2013
Testosterone Draft Transdermal Gel 021015 11/2013
Testosterone Draft Transdermal Gel 021454 04/2013
Testosterone Draft Transdermal Gel 022309 11/2013
Testosterone Draft Transdermal Solution, Metered 022504 04/2013
Testosterone Draft Transdermal Film, Extended Release 020489 11/2019
Testosterone Draft Implantation Pellet 080911 08/2011
Testosterone Final Buccal Tablet, Extended Release 021543 05/2008
Testosterone Undecanoate Draft Oral Capsule 206089 03/2021
Tetrabenazine tablet_RLD21894_RV05-17.pdf Draft Oral Tablet 021894 07/2017
Tetracaine Hydrochloride Draft Ophthalmic Solution 208135 11/2019
Tetracycline Hydrochloride Draft Oral Capsule 050278 02/2010
Thalidomide Draft Oral Capsule 020785 021430 12/2012
Theophylline Draft Oral Tablet, Extended Release 600 MG 040560 08/2020
Theophylline Draft Oral Capsule, Extended Release 081034 08/2020
Thioguanine Draft Oral Tablet 012429 09/2012
Thioridazine Hydrochloride Draft Oral Tablet 011808 09/2019
Thiothixene capsule_NDA 016584_RC Oct 2018.pdf Draft Oral Capsule 016584 11/2018
Tiagabine Hydrochloride HCl_oral tablet_RLD 20646_Final 08-17.pdf Final Oral Tablet 020646 08/2017
Ticagrelor tablet_NDA 022433_RV07-18.pdf Draft Oral Tablet 022433 07/2018
Ticlopidine Hydrochloride Final Oral Tablet 019979 05/2008
Timolol Maleate Draft Oral Tablet 072668 06/2013
Timolol Maleate Maleate Ophthalmic Solution NDA 018086 PSG Page RC May 2019.pdf Draft Ophthalmic Drops, Solution 018086 05/2019
Timolol Maleate Draft Ophthalmic Solution, Gel Forming/Drops 020330 11/2019
Tinidazole Draft Oral Tablet 021618 11/2019
Tioconazole Draft Vaginal Ointment 020676 03/2011
Tiopronin tablet_NDA 19569_RC05-17.pdf Draft Oral Tablet 019569 07/2017
Tiopronin Draft Oral Tablet, Delayed Release 211843 03/2020
Tiotropium Bromide Draft Inhalation Spray, Metered 021936 11/2020
Tiotropium Bromide bromide_inhalation powder_NDA 021395_RC10-17.pdf Draft Inhalation Powder 021395 10/2017
Tipiracil Hydrochloride; Trifluridine Draft Oral Tablet 207981 11/2019
Tipranavir Draft Oral Capsule 021814 11/2007
Tizanidine Hydrochloride Draft Oral Tablet 020397 11/2010
Tizanidine Hydrochloride Final Oral Capsule 021447 05/2008
Tobramycin ophthalmic ointment 0.3 NDA 050555 PSG Page RC May 2019.pdf Draft Ophthalmic Ointment 050555 05/2019
Tofacitinib Citrate Draft Oral Tablet, Extended Release 208246 05/2021
Tofacitinib Citrate Citrate Oral Tablet NDA 203214 PSG Page RV May 2019.pdf Draft Oral Tablet 203214 05/2019
Tolcapone tablet_020697_RC06-15.pdf Draft Oral Tablet 020697 06/2015
Tolterodine Tartrate Final Oral Tablet 020771 05/2008
Tolterodine Tartrate Draft Oral Capsules, Extended Release 021228 09/2012
Tolvaptan Draft Oral Tablet 022275 03/2012
Tolvaptan Draft Oral Tablet 204441 03/2020
Topiramate Draft Oral Tablet 020505 06/2013
Topiramate Draft Oral Capsule 020844 06/2013
Topiramate ER Cap_205122_RC03-15.pdf Draft Oral Capsule, Extended Release 205122 03/2015
Topiramate Draft Oral Capsule, Extended Release 201635 03/2015
Topotecan Hydrochloride Draft Oral Capsule 020981 03/2011
Toremifene Citrate Final Oral Tablet 020497 10/2011
Torsemide Final Oral Tablet 020136 05/2008
Tramadol Hydrochloride hydrochloride_Oral ER capsule_22370_RC09-15.pdf Draft Oral Capsule, Extended Release 022370 09/2015
Tramadol Hydrochloride Final Oral Tablet 020281 05/2008
Tramadol Hydrochloride Draft Oral Tablet, Extended Release 021692 11/2007
Trametinib Dimethyl Sulfoxide dimethyl sulfoxide_oral tablet_RLD 204114_RC01-16.pdf Draft Oral Tablet 204114 01/2016
Trandolapril Final Oral Tablet 020528 05/2008
Trandolapril; Verapamil Hydrochloride;_Verapamil_ERtab_20591_RC12-08.pdf Draft Oral Tablet, Extended Release 020591 12/2008
Tranexamic Acid Draft Oral Tablet 022430 03/2011
Tranylcypromine Sulfate Draft Oral Tablet 012342 04/2014
Trazodone Hydrochloride Draft Oral Tablet, Extended Release 022411 09/2012
Trazodone Hydrochloride Draft Oral Tablet 018207 02/2010
Treprostinil Diolamine diolamine oral extended release tablet NDA 203496 RV Feb 2019.pdf Draft Oral Tablet, Extended Release 203496 02/2019
Tretinoin Topical Cream ANDA 090098 RV Feb 2019.pdf Draft Topical Cream 090098 02/2019
Tretinoin Draft Oral Capsule 020438 09/2010
Tretinoin Draft Topical Gel 022070 06/2020
Tretinoin Draft Topical Cream 021108 06/2020
Tretinoin Draft Topical Gel 020475 06/2020
Tretinoin Draft Topical Cream 019963 06/2020
Tretinoin Draft Topical Cream 019049 06/2020
Tretinoin Draft Topical Gel 017955 06/2020
Tretinoin Draft Topical Gel 017579 06/2020
Tretinoin Draft Topical Cream 017522 06/2020
Tretinoin Draft Topical Cream 017340 06/2020
Tretinoin Draft Topical Lotion 209353 06/2020
Tretinoin Draft Topical Solution 016921 09/2019
Triamcinolone acetonide acetonide_intravitreal injectable_NDA 022048_RC07-18.pdf Draft Intravitreal Injectable 022048 07/2018
Triamcinolone Acetonide Draft Nasal Spray, Metered 020468 06/2020
Triamcinolone Acetonide acetonide_topical lotion_NDA 011602_RC05-16.pdf Draft Topical Lotion 011602 07/2017
Triamcinolone Acetonide acetonide_topical ointment_ANDA 087356_RC05-17.pdf Draft Topical Ointment 0.5% 087385 07/2017
Triamcinolone Acetonide acetonide_topical ointment_RLD 087385_RC09-16.pdf Draft Topical Ointment 0.025% 087385 10/2016
Triamcinolone Acetonide acetonide_topical cream_RLD 085692_RC04-16.pdf Draft Topical Cream 011601 04/2016
Triamcinolone Acetonide acetonide_topical ointment_RLD 087357_RC04-16.pdf Draft Topical Ointment 0.1% 087385 04/2016
Triamcinolone Acetonide acetonide_topical ointment_RLD 089595_RC04-16.pdf Draft Topical Ointment 089595 04/2016
Triamcinolone Acetonide acetonide_injectable suspension_NDA 012041; 014901_RV07-18.pdf Draft Injectable Suspension 012041 014901 07/2018
Triamcinolone Acetonide acetonide_dental paste_NDA 012097_RV11-17.pdf Draft Dental Paste 012097 02/2018
Triamterene capsule_NDA 013174_RV Oct 2018.pdf Draft Oral Capsule 013174 11/2018
Triazolam Draft Oral Tablet 017892 08/2010
Triclabendazole Draft Oral Tablet 208711 06/2020
Trientine Hydrochloride Draft Oral Capsule 019194 06/2013
Trifarotene Draft Topical Cream 211527 05/2021
Trimethoprim Draft Oral Tablet 018679 02/2010
Trimipramine Maleate maleate_oral capsule_ 016792_RC09-15.pdf Draft Oral Capsule 016792 09/2015
Triptorelin Pamoate pamoate_IMinj_20715_21288_22437_RV02-14.pdf Draft Intramuscular Injectable 020715 021288 022437 208956 02/2014
Trospium Chloride chloride_oral ER capsule_RLD 22102 and ANDA 91289_RV03-17.pdf Draft Oral Capsule, Extended Release 022103 05/2017
Trospium Chloride chloride_oral tablet_RLD (21595) and 91575_RV03-17.pdf Draft Oral Tablet 021595 05/2017

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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