Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to www.fda.gov, 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 esub@fda.hhs.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

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 regulations.gov website (https://www.regulations.gov/help). 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 Regulations.gov 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 https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tacrolimus_oral ER tablet_RLD 206406_RC06-16.pdf Draft Oral Tablet, Extended Release 206406 06/2016
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tacrolimus topical ointment 0.1 NDA 050777 PSG Page RV 09_2018.pdf Draft Topical Ointment 0.1% 050777 09/2018
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG for Tacrolimus Ointment 0.03 2018-09-13.pdf Draft Topical Ointment 0.03% 050777 09/2018
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tacrolimus_ERcap_204096_RC07-14.pdf Draft Oral Capsule, Extended Release 204096 07/2014
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tacrolimus_cap_50708_RV12-12.pdf Draft Oral Capsule 050708 12/2012
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210115.pdf Draft Oral For Suspension 210115 03/2020
Tadalafil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tadalafil_oral tablet_NDA 022332 and NDA 21368_RV08-17.pdf Draft Oral Tablet 021368 022332 10/2017
Tafamidis https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212161.pdf Draft Oral Capsule 212161 11/2020
Tafamidis Meglumine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211996.pdf Draft Oral Capsule 211996 11/2020
Tafenoquine Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210795.pdf Draft Oral Tablet 210795 06/2020
Tafenoquine Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210607.pdf Draft Oral Tablet 210607 08/2020
Talazoparib Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211651.pdf Draft Oral Capsule 211651 06/2020
Talc https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205555.pdf Draft Intrapleural Powder 205555 08/2020
Talc https://www.accessdata.fda.gov/drugsatfda_docs/psg/Talc intrapleural aerosol NDA 020587 RC 09-2018.pdf Draft Inhalation Aerosol, Metered 020587 09/2018
Tamoxifen Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tamoxifen_Citrate_tab_74858_75797_RC5-09.pdf Final Oral Tablet 017970 10/2011
Tamsulosin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ucm090564.pdf Final Oral Capsule 020579 05/2008
Tapentadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tapentadol_ ERTabs_200533_RC09-10.pdf Draft Oral Tablet, Extended Release 200533 06/2012
Tapentadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tapentadol_HCl_tab_22304_RC11-10.pdf Draft Oral Tablet 022304 11/2010
Tasimelteon https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tasimelteon_oral capsule_205677_RC09-15.pdf Draft Oral Capsule 205677 09/2015
Tavaborole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tavaborole topical solution NDA 204427 RC 09-2018.pdf Draft Topical Solution 204427 09/2018
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.05P.pdf Draft Topical Cream 0.05% 021184 08/2021
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202428.pdf Draft Topical Aerosol, Foam 202428 11/2019
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/TazaroteneTopicalGel0.05NDA020600RVFeb2019.pdf Draft Topical Gel 0.05% 020600 02/2019
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tazarotene Cream 0.1_NDA 021184 RV Feb 2019.pdf Draft Topical Cream 0.1% 021184 02/2019
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020600-Gel-0.1P.pdf Draft Topical Gel 0.1% 020600 11/2019
Tazemetostat Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211723.pdf Draft Oral Tablet 211723 08/2021
Tecovirimat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208627.pdf Draft Oral Capsule 208627 09/2019
Tedizolid Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tedizolid phosphate_oral tablet_RLD 205435_RV12-16.pdf Draft Oral Tablet 205435 12/2016
Telaprevir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telaprevir_tab_201917_RC09-12.pdf Draft Oral Tablet 201917 09/2012
Telbivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telbivudine_tab_22011_RC8-09.pdf Final Oral Tablet 022011 10/2011
Telithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telithromycin_tab_21144_ RC7-06.pdf Final Oral Tablet 021144 05/2008
Telmisartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telmisartan_tabs_20850_RC5-08.pdf Draft Oral Tablet 020850 10/2010
Telotristat Etiprate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telotristat etiprate_oral tablet_NDA 208794_RC08-17.pdf Draft Oral Tablet 208794 10/2017
Temazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Temazepam_cap_18163_RC4-09.pdf Final Oral Capsule 018163 10/2011
Temozolomide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Temozolomide_cap_21029_RC12-08.pdf Draft Oral Capsule 021029 07/2009
Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tenofovir alafenamide fumarate_oral tablet_NDA 208464_RC05-17.pdf Draft Oral Tablet 208464 07/2017
Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tenofovir Disoproxil Fumarate 022577 RC09-12.pdf Draft Oral Powder 022577 09/2012
Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tenofovir Disoproxil Fumarate_oral tablet_RLD 21356_Final 08-17.pdf Final Oral Tablet 021356 08/2017
Terazosin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020347.pdf Draft Oral Capsule 020347 11/2019
Terbinafine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terbinafine Hydrochloride Topical Cream NDA 020980 RV Feb 2019.pdf Draft Topical Cream 020980 02/2019
Terbinafine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terbinafine_HCl_tab_22071_RC4-09.pdf Final Oral Granule 022071 10/2011
Terbinafine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terbinafine_HCl_tab_20539_RC3-05.pdf Final Oral Tablet 020539 05/2008
Terbutaline Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terbutaline sulfate_oral tablet_NDA 017849_RC08-17.pdf Draft Oral Tablet 017849 10/2017
Terconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terconazole_VagCrm_19579_RC2-10.pdf Draft Vaginal Cream 019579 02/2010
Terconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terconazole_VagCrm_19964_RC2-10.pdf Draft Vaginal Cream 019964 02/2010
Terconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terconazole_VagSupp_19641_RC2-10.pdf Draft Vaginal Suppository 019641 02/2010
Teriflunomide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Teriflunomide_tab_202992_RV03-15.pdf Draft Oral Tablet 202992 03/2015
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_metered_transdermal_1_21015_RV11-13.pdf Draft Transdermal Gel, Metered 1% 021015 11/2013
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_metered_transdermal_1.62_22309_RV11-13.pdf Draft Transdermal Gel, Metered 022309 11/2013
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_metered_transdermal_10 mg 0.5 gm gel_21463_RC04-13.pdf Draft Transdermal Gel, Metered 021463 04/2013
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_transdermal_1_21015_RV11-13.pdf Draft Transdermal Gel 021015 11/2013
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_transdermal_1_21454_RC04-13.pdf Draft Transdermal Gel 021454 04/2013
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_transdermal_1.62_22309_RV11-13.pdf Draft Transdermal Gel 022309 11/2013
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_solution_22504_RC04-13.pdf Draft Transdermal Solution, Metered 022504 04/2013
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020489.pdf Draft Transdermal Film, Extended Release 020489 11/2019
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_pellet_80911_RC08-11.pdf Draft Implantation Pellet 080911 08/2011
Testosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_ERbuccal_21543_RC10-06.pdf Final Buccal Tablet, Extended Release 021543 05/2008
Testosterone Undecanoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206089.pdf Draft Oral Capsule 206089 03/2021
Tetrabenazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tetrabenazine_oral tablet_RLD21894_RV05-17.pdf Draft Oral Tablet 021894 07/2017
Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208135.pdf Draft Ophthalmic Solution 208135 11/2019
Tetracycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tetracycline_HCl_cap_60704_RC2-10.pdf Draft Oral Capsule 050278 02/2010
Thalidomide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Thalidomide_cap_20785_21430_RV12-12.pdf Draft Oral Capsule 020785 021430 12/2012
Theophylline https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_085328-TabER-600MG.pdf Draft Oral Tablet, Extended Release 600 MG 040560 08/2020
Theophylline https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_087942.pdf Draft Oral Capsule, Extended Release 081034 08/2020
Thioguanine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Thioguanine_Tabs_012429_RC09-12.pdf Draft Oral Tablet 012429 09/2012
Thioridazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011808.pdf Draft Oral Tablet 011808 09/2019
Thiothixene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Thiothixene_Oral capsule_NDA 016584_RC Oct 2018.pdf Draft Oral Capsule 016584 11/2018
Tiagabine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tiagabine HCl_oral tablet_RLD 20646_Final 08-17.pdf Final Oral Tablet 020646 08/2017
Ticagrelor https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ticagrelor_oral tablet_NDA 022433_RV07-18.pdf Draft Oral Tablet 022433 07/2018
Ticlopidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ticlopidine_HCl_tab_19979_RC3-05.pdf Final Oral Tablet 019979 05/2008
Timolol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Timolol_maleate_tab_072668_RC06-13.pdf Draft Oral Tablet 072668 06/2013
Timolol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Timolol Maleate Ophthalmic Solution NDA 018086 PSG Page RC May 2019.pdf Draft Ophthalmic Drops, Solution 018086 05/2019
Timolol Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020330.pdf Draft Ophthalmic Solution, Gel Forming/Drops 020330 11/2019
Tinidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021618.pdf Draft Oral Tablet 021618 11/2019
Tioconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tioconazole_vagcrm_20676_RC03-11.pdf Draft Vaginal Ointment 020676 03/2011
Tiopronin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tiopronin_oral tablet_NDA 19569_RC05-17.pdf Draft Oral Tablet 019569 07/2017
Tiopronin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211843.pdf Draft Oral Tablet, Delayed Release 211843 03/2020
Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021936.pdf Draft Inhalation Spray, Metered 021936 11/2020
Tiotropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tiotropium bromide_inhalation powder_NDA 021395_RC10-17.pdf Draft Inhalation Powder 021395 10/2017
Tipiracil Hydrochloride; Trifluridine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207981.pdf Draft Oral Tablet 207981 11/2019
Tipranavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tipranavir_cap_21814_RC11-07.pdf Draft Oral Capsule 021814 11/2007
Tizanidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tizanidine_HCl_tabs_20397_RC11-10.pdf Draft Oral Tablet 020397 11/2010
Tizanidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tizanidine_HCl_cap_21447_RC2-06.pdf Final Oral Capsule 021447 05/2008
Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tobramycin ophthalmic ointment 0.3 NDA 050555 PSG Page RC May 2019.pdf Draft Ophthalmic Ointment 050555 05/2019
Tofacitinib Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208246.pdf Draft Oral Tablet, Extended Release 208246 05/2021
Tofacitinib Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tofacitinib Citrate Oral Tablet NDA 203214 PSG Page RV May 2019.pdf Draft Oral Tablet 203214 05/2019
Tolcapone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tolcapone_Oral tablet_020697_RC06-15.pdf Draft Oral Tablet 020697 06/2015
Tolterodine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tolterodine_Tartrate_tab_20771_RC3-05.pdf Final Oral Tablet 020771 05/2008
Tolterodine Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tolterodine_ER_Capsules_021228_RC09-12.pdf Draft Oral Capsules, Extended Release 021228 09/2012
Tolvaptan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tolvaptan_tab_22275_RC03-12.pdf Draft Oral Tablet 022275 03/2012
Tolvaptan https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204441.pdf Draft Oral Tablet 204441 03/2020
Topiramate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topiramate_tab_20505_RV06-13.pdf Draft Oral Tablet 020505 06/2013
Topiramate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topiramate_cap_20844_RV06-13.pdf Draft Oral Capsule 020844 06/2013
Topiramate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topiramate_ ER Cap_205122_RC03-15.pdf Draft Oral Capsule, Extended Release 205122 03/2015
Topiramate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topiramate_ERcap_201635_RC03-15.pdf Draft Oral Capsule, Extended Release 201635 03/2015
Topotecan Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topotecan_caps_20981_RC03-11.pdf Draft Oral Capsule 020981 03/2011
Toremifene Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Toremifene_Citrate_tab_20497_RC4-09.pdf Final Oral Tablet 020497 10/2011
Torsemide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Torsemide_tab_20136_RC1-06.pdf Final Oral Tablet 020136 05/2008
Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tramadol hydrochloride_Oral ER capsule_22370_RC09-15.pdf Draft Oral Capsule, Extended Release 022370 09/2015
Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tramadol_HCl_tab_20281_RC7-03.pdf Final Oral Tablet 020281 05/2008
Tramadol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tramadol_HCl_ERtab_21692-_RC11-07.pdf Draft Oral Tablet, Extended Release 021692 11/2007
Trametinib Dimethyl Sulfoxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trametinib dimethyl sulfoxide_oral tablet_RLD 204114_RC01-16.pdf Draft Oral Tablet 204114 01/2016
Trandolapril https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trandolapril_tab_20528_RC12-05.pdf Final Oral Tablet 020528 05/2008
Trandolapril; Verapamil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trandolapril;_Verapamil_ERtab_20591_RC12-08.pdf Draft Oral Tablet, Extended Release 020591 12/2008
Tranexamic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tranexamic_Acid_22430_RC12-10.pdf Draft Oral Tablet 022430 03/2011
Tranylcypromine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tranylcypromine_sulfate_tab_12342_RC02-14.pdf Draft Oral Tablet 012342 04/2014
Trazodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trazodone_HCl_ERtab_22411_RC09-12.pdf Draft Oral Tablet, Extended Release 022411 09/2012
Trazodone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trazodone_HCl_tab_71196_71258_RC2-10.pdf Draft Oral Tablet 018207 02/2010
Treprostinil Diolamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Treprostinil diolamine oral extended release tablet NDA 203496 RV Feb 2019.pdf Draft Oral Tablet, Extended Release 203496 02/2019
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin Topical Cream ANDA 090098 RV Feb 2019.pdf Draft Topical Cream 090098 02/2019
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Caps_77684_RC09-10.pdf Draft Oral Capsule 020438 09/2010
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022070.pdf Draft Topical Gel 022070 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021108.pdf Draft Topical Cream 021108 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020475.pdf Draft Topical Gel 020475 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019963.pdf Draft Topical Cream 019963 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019049.pdf Draft Topical Cream 019049 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017955.pdf Draft Topical Gel 017955 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017579.pdf Draft Topical Gel 017579 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017522.pdf Draft Topical Cream 017522 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017340.pdf Draft Topical Cream 017340 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209353.pdf Draft Topical Lotion 209353 06/2020
Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016921.pdf Draft Topical Solution 016921 09/2019
Triamcinolone acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_intravitreal injectable_NDA 022048_RC07-18.pdf Draft Intravitreal Injectable 022048 07/2018
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020468.pdf Draft Nasal Spray, Metered 020468 06/2020
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_topical lotion_NDA 011602_RC05-16.pdf Draft Topical Lotion 011602 07/2017
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_topical ointment_ANDA 087356_RC05-17.pdf Draft Topical Ointment 0.5% 087385 07/2017
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_topical ointment_RLD 087385_RC09-16.pdf Draft Topical Ointment 0.025% 087385 10/2016
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_topical cream_RLD 085692_RC04-16.pdf Draft Topical Cream 011601 04/2016
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_topical ointment_RLD 087357_RC04-16.pdf Draft Topical Ointment 0.1% 087385 04/2016
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_topical ointment_RLD 089595_RC04-16.pdf Draft Topical Ointment 089595 04/2016
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_injectable suspension_NDA 012041; 014901_RV07-18.pdf Draft Injectable Suspension 012041 014901 07/2018
Triamcinolone Acetonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_dental paste_NDA 012097_RV11-17.pdf Draft Dental Paste 012097 02/2018
Triamterene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamterene_Oral capsule_NDA 013174_RV Oct 2018.pdf Draft Oral Capsule 013174 11/2018
Triazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triazolam_tabs_17892_RC08-10.pdf Draft Oral Tablet 017892 08/2010
Triclabendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208711.pdf Draft Oral Tablet 208711 06/2020
Trientine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trientine_HCl_caps_019194_RC06-13.pdf Draft Oral Capsule 019194 06/2013
Trifarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211527.pdf Draft Topical Cream 211527 05/2021
Trimethoprim https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trimethoprim_tabs_71259_18679_RC2-10.pdf Draft Oral Tablet 018679 02/2010
Trimipramine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trimipramine maleate_oral capsule_ 016792_RC09-15.pdf Draft Oral Capsule 016792 09/2015
Triptorelin Pamoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triptorelin pamoate_IMinj_20715_21288_22437_RV02-14.pdf Draft Intramuscular Injectable 020715 021288 022437 208956 02/2014
Trospium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trospium chloride_oral ER capsule_RLD 22102 and ANDA 91289_RV03-17.pdf Draft Oral Capsule, Extended Release 022103 05/2017
Trospium Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trospium 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 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202408.pdf Draft Ophthalmic Ointment 202408 08/2021
Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/2021
Amisulpride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209510.pdf Draft Intravenous Solution 209510 08/2021
Avapritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212608.pdf Draft Oral Tablet 212608 08/2021
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008915.pdf Draft Oral Tablet 008915 08/2021
Cefiderocol Sulfate Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209445.pdf Draft Intravenous Powder 209445 08/2021
Copper Dotatate Cu-64 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213227.pdf Draft Intravenous Solution 213227 08/2021
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214278.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021166.pdf Draft Transdermal Gel, Metered 021166 08/2021
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204017.pdf Draft Transdermal System 204017 08/2021
Fostemsavir Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212950.pdf Draft Oral Tablet, Extended Release 212950 08/2021
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017814.pdf Draft Rectal Suppository 017814 08/2021
Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020393.pdf Draft Nasal Spray, Metered 020393 020394 08/2021
Lasmiditan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211280.pdf Draft Oral Tablet 211280 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021343.pdf Draft Subcutaneous Powder 021343 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208219.pdf Draft Ophthalmic Gel 208219 08/2021
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/2021
Osilodrostat Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212801.pdf Draft Oral Tablet 212801 08/2021
Ozanimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209899.pdf Draft Oral Capsule 209899 08/2021
Paliperidone Palmitate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207946.pdf Draft Intramuscular Suspension, Extended Release 207946 08/2021
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213051.pdf Draft Oral Tablet 213051 08/2021
Sufentanil Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209128.pdf Draft Sublingual Tablet 209128 08/2021
Tazemetostat Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211723.pdf 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 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf Draft Oral Capsule 021055 08/2021
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021324.pdf Draft Oral Capsule, Delayed Release 021324 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022291.pdf Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207027.pdf Draft Oral For Suspension 207027 08/2021
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205109.pdf Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021135.pdf Draft Intravenous Injectable 021135 09/2021
Letrozole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020726.pdf Draft Oral Tablet 020726 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019732.pdf Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020517.pdf Draft Injection Injectable 020517 020708 08/2021
Liothyronine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010379.pdf Draft Oral Tablet 010379 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf Draft Ophthalmic Suspension/Drops 020583 08/2021
Nystatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060578.pdf Draft Topical Powder 065203 08/2021
Orlistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020766.pdf Draft Oral Capsule 020766 021887 08/2021
Paclitaxel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021660.pdf Draft IV Infusion For Suspension 021660 08/2021
Podofilox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020529.pdf Draft Topical Gel 020529 08/2021
Sodium Zirconium Cyclosilicate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207078.pdf Draft Oral For Suspension 207078 08/2021
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.05P.pdf Draft Topical Cream 0.05% 021184 08/2021

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