Product-Specific Guidances for Generic Drug Development
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 RLD.
According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence (BE) for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate BE depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct BE 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 facilitate generic drug product availability and further assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, the FDA publishes product-specific guidances (PSG). PSGs describe the Agency's current thinking and expectations to develop generic drug products therapeutically equivalent to specific RLDs.
The FDA publishes PSGs to foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs.
PSGs 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.
The implementation of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 20221 (GDUFA III). with regard to issuance of PSGs is effective on October 1, 2022. Under GDUFA III, the FDA will issue PSGs consistent with the following goals:
- For complex products1,2 approved in new drug applications (NDAs) on or after October 1, 2022, a PSG will be issued for 50 percent of such NDA products within two years after the date of approval, and for 75 percent of such NDA products within three years after the date of approval.
- FDA will continue to develop PSGs for complex products approved prior to October 1, 2022, for which no PSG has been published.
- For non-complex drug products approved in NDAs on or after October 1, 2022, that contain a new chemical entity (NCE) (as described in section 505(j)(5)(F)(ii) of the FD&C Act), a PSG will be issued within two years after the date of approval for 90 percent of such products.
The FDA also evaluates drug availability and accessibility and considers public health priorities, including but not limited to, public health emergencies and drug safety and efficacy updates. In addition to these elements, the FDA continually assesses the status and outcomes of ongoing GDUFA research to ensure there are sufficient and adequate data and evidence to support the development of PSGs that align with the FDA's current scientific thinking.
Sponsors and investigators of any investigational new drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or 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.
In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or 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 PSGs 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 (www.regulations.gov). 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) or at (www.regulations.gov/support) for assistance regarding submissions.
The FDA posts plans for issuing new or revised PSGs on the Upcoming Product-Specific Guidances for Generic Drug Product Development web page
For additional information on development of generic drug products, please refer to FDA's guidance document database.
1
2
Total number of currently published PSGs: 2223
165 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_cap_50708_RV12-12.pdf | Draft | Oral | Capsule | 050708 | 12/14/2012 |
| Tacrolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tacrolimus_ERcap_204096_RC07-14.pdf | Draft | Oral | Capsule, Extended Release | 204096 | 07/22/2014 |
| Tacrolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210115.pdf | Draft | Oral | For Suspension | 210115 | 08/02/2022 |
| Tacrolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206406.pdf | Draft | Oral | Tablet, Extended Release | 206406 | 08/22/2024 |
| Tacrolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050777-Oin-0.1P.pdf | Draft | Topical | Ointment 0.1% | 050777 | 10/21/2022 |
| Tacrolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050777-Oin-0.03P.pdf | Draft | Topical | Ointment 0.03% | 050777 | 10/21/2022 |
| 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 | 10/19/2017 |
| Tafamidis | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212161.pdf | Draft | Oral | Capsule | 212161 | 11/18/2020 |
| Tafamidis Meglumine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211996.pdf | Draft | Oral | Capsule | 211996 | 11/18/2020 |
| Tafenoquine Succinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210795.pdf | Draft | Oral | Tablet | 210795 | 06/03/2020 |
| Tafenoquine Succinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210607.pdf | Draft | Oral | Tablet | 210607 | 08/28/2020 |
| Tafluprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202514.pdf | Draft | Ophthalmic | Solution, Drops | 202514 | 08/22/2024 |
| Talazoparib Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211651.pdf | Draft | Oral | Capsule | 211651 | 06/03/2020 |
| Talc | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Talc intrapleural aerosol NDA 020587 RC 09-2018.pdf | Draft | Inhalation | Aerosol, Metered | 020587 | 09/13/2018 |
| Talc | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205555.pdf | Draft | Intrapleural | Powder | 205555 | 08/28/2020 |
| Tamoxifen Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tamoxifen_Citrate_tab_74858_75797_RC5-09.pdf | Final | Oral | Tablet | 017970 | 10/28/2011 |
| Tamsulosin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/ucm090564.pdf | Final | Oral | Capsule | 020579 | 05/12/2008 |
| Tapentadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tapentadol_HCl_tab_22304_RC11-10.pdf | Draft | Oral | Tablet | 022304 | 11/26/2010 |
| Tapentadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200533.pdf | Draft | Oral | Tablet, Extended Release | 200533 | 08/22/2024 |
| Tapinarof | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215272.pdf | Draft | Topical | Cream | 215272 | 11/16/2023 |
| Tasimelteon | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214517.pdf | Draft | Oral | Suspension | 214517 | 05/16/2024 |
| Tasimelteon | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tasimelteon_oral capsule_205677_RC09-15.pdf | Draft | Oral | Capsule | 205677 | 09/18/2015 |
| Tavaborole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tavaborole topical solution NDA 204427 RC 09-2018.pdf | Draft | Topical | Solution | 204427 | 09/13/2018 |
| Tazarotene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020600-Gel-0.1P.pdf | Draft | Topical | Gel 0.1% | 020600 | 10/21/2022 |
| Tazarotene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.05P.pdf | Draft | Topical | Cream 0.05% | 021184 | 08/20/2021 |
| Tazarotene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.1P.pdf | Draft | Topical | Cream 0.1% | 021184 | 10/21/2022 |
| Tazarotene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020600-Gel-0.05P.pdf | Draft | Topical | Gel 0.05% | 020600 | 10/21/2022 |
| Tazarotene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211882.pdf | Draft | Topical | Lotion | 211882 | 10/21/2022 |
| Tazarotene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202428.pdf | Draft | Topical | Aerosol, Foam | 202428 | 11/21/2019 |
| Tazemetostat Hydrobromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211723.pdf | Draft | Oral | Tablet | 211723 | 08/20/2021 |
| Technetium Tc-99m Sodium Pertechnetate Generator | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202158.pdf | Draft | Intravenous, Intravesicular, Ophthalmic | Solution | 202158 | 08/02/2022 |
| Tecovirimat | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208627.pdf | Draft | Oral | Capsule | 208627 | 09/16/2019 |
| Tedizolid Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tedizolid phosphate_oral tablet_RLD 205435_RV12-16.pdf | Draft | Oral | Tablet | 205435 | 12/22/2016 |
| Tegaserod Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021200.pdf | Draft | Oral | Tablet | 021200 | 05/19/2022 |
| Telaprevir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telaprevir_tab_201917_RC09-12.pdf | Draft | Oral | Tablet | 201917 | 09/19/2012 |
| Telbivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telbivudine_tab_22011_RC8-09.pdf | Final | Oral | Tablet | 022011 | 10/28/2011 |
| Telithromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telithromycin_tab_21144_ RC7-06.pdf | Final | Oral | Tablet | 021144 | 05/12/2008 |
| Telmisartan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telmisartan_tabs_20850_RC5-08.pdf | Draft | Oral | Tablet | 020850 | 10/22/2010 |
| Telotristat Etiprate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Telotristat etiprate_oral tablet_NDA 208794_RC08-17.pdf | Draft | Oral | Tablet | 208794 | 10/19/2017 |
| Temazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Temazepam_cap_18163_RC4-09.pdf | Final | Oral | Capsule | 018163 | 10/28/2011 |
| Temozolomide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Temozolomide_cap_21029_RC12-08.pdf | Draft | Oral | Capsule | 021029 | 07/01/2009 |
| Tenapanor Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211801.pdf | Draft | Oral | Tablet | 211801 | 11/08/2021 |
| 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 | 07/13/2017 |
| 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 | 08/04/2017 |
| Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tenofovir Disoproxil Fumarate 022577 RC09-12.pdf | Draft | Oral | Powder | 022577 | 09/19/2012 |
| Tepotinib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214096.pdf | Draft | Oral | Tablet | 214096 | 11/17/2022 |
| Terazosin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020347.pdf | Draft | Oral | Capsule | 020347 | 11/21/2019 |
| Terbinafine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terbinafine_HCl_tab_20539_RC3-05.pdf | Final | Oral | Tablet | 020539 | 05/12/2008 |
| Terbinafine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terbinafine_HCl_tab_22071_RC4-09.pdf | Final | Oral | Granule | 022071 | 10/28/2011 |
| Terbinafine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terbinafine Hydrochloride Topical Cream NDA 020980 RV Feb 2019.pdf | Draft | Topical | Cream | 020980 | 02/22/2019 |
| Terbutaline Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terbutaline sulfate_oral tablet_NDA 017849_RC08-17.pdf | Draft | Oral | Tablet | 017849 | 10/19/2017 |
| Terconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terconazole_VagCrm_19579_RC2-10.pdf | Draft | Vaginal | Cream | 019579 | 02/25/2010 |
| Terconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terconazole_VagCrm_19964_RC2-10.pdf | Draft | Vaginal | Cream | 019964 | 02/25/2010 |
| Terconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Terconazole_VagSupp_19641_RC2-10.pdf | Draft | Vaginal | Suppository | 019641 | 02/25/2010 |
| Teriflunomide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Teriflunomide_tab_202992_RV03-15.pdf | Draft | Oral | Tablet | 202992 | 03/06/2015 |
| Teriparatide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021318.pdf | Draft | Subcutaneous | Solution | 021318 | 08/22/2024 |
| Terlipressin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022231.pdf | Draft | Intravenous | Powder | 022231 | 02/15/2024 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205488.pdf | Draft | Nasal | Gel, Metered | 205488 | 02/16/2023 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_ERbuccal_21543_RC10-06.pdf | Final | Buccal | Tablet, Extended Release | 021543 | 05/12/2008 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_080911.pdf | Draft | Implantation | Pellet | 080911 | 05/05/2022 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_solution_22504_RC04-13.pdf | Draft | Transdermal | Solution, Metered | 022504 | 04/05/2013 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020489.pdf | Draft | Transdermal | Film, Extended Release | 020489 | 11/21/2019 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_transdermal_1_21015_RV11-13.pdf | Draft | Transdermal | Gel | 021015 | 11/05/2013 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_transdermal_1_21454_RC04-13.pdf | Draft | Transdermal | Gel | 021454 | 04/05/2013 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_transdermal_1.62_22309_RV11-13.pdf | Draft | Transdermal | Gel | 022309 | 11/05/2013 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_metered_transdermal_1_21015_RV11-13.pdf | Draft | Transdermal | Gel, Metered 1% | 021015 | 11/05/2013 |
| Testosterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Testosterone_gel_metered_transdermal_1.62_22309_RV11-13.pdf | Draft | Transdermal | Gel, Metered | 022309 | 11/05/2013 |
| 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 | 04/05/2013 |
| Testosterone Undecanoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206089.pdf | Draft | Oral | Capsule | 206089 | 03/24/2021 |
| Testosterone Undecanoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213953.pdf | Draft | Oral | Capsule | 213953 | 02/15/2024 |
| Tetrabenazine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tetrabenazine_oral tablet_RLD21894_RV05-17.pdf | Draft | Oral | Tablet | 021894 | 07/13/2017 |
| Tetracaine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208135.pdf | Draft | Ophthalmic | Solution | 208135 | 11/21/2019 |
| Tetracycline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tetracycline_HCl_cap_60704_RC2-10.pdf | Draft | Oral | Capsule | 050278 | 02/25/2010 |
| Thalidomide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Thalidomide_cap_20785_21430_RV12-12.pdf | Draft | Oral | Capsule | 020785 021430 | 12/14/2012 |
| Theophylline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_087942.pdf | Draft | Oral | Capsule, Extended Release | 081034 | 08/28/2020 |
| Theophylline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_085328.pdf | Draft | Oral | Tablet, Extended Release | 090430 086998 085328 | 05/19/2022 |
| Theophylline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_085328-TabER-600MG.pdf | Draft | Oral | Tablet, Extended Release 600 MG | 040560 | 08/28/2020 |
| Thioguanine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Thioguanine_Tabs_012429_RC09-12.pdf | Draft | Oral | Tablet | 012429 | 09/19/2012 |
| Thioridazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011808.pdf | Draft | Oral | Tablet | 011808 | 09/16/2019 |
| Thiothixene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Thiothixene_Oral capsule_NDA 016584_RC Oct 2018.pdf | Draft | Oral | Capsule | 016584 | 11/28/2018 |
| Tiagabine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tiagabine HCl_oral tablet_RLD 20646_Final 08-17.pdf | Final | Oral | Tablet | 020646 | 08/04/2017 |
| Ticagrelor | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ticagrelor_oral tablet_NDA 022433_RV07-18.pdf | Draft | Oral | Tablet | 022433 | 07/20/2018 |
| Ticlopidine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ticlopidine_HCl_tab_19979_RC3-05.pdf | Final | Oral | Tablet | 019979 | 05/01/2008 |
| Timolol Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Timolol_maleate_tab_072668_RC06-13.pdf | Draft | Oral | Tablet | 072668 | 06/19/2013 |
| Timolol Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020330.pdf | Draft | Ophthalmic | Solution, Gel Forming/Drops | 020330 | 11/21/2019 |
| Timolol Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Timolol Maleate Ophthalmic Solution NDA 018086 PSG Page RC May 2019.pdf | Draft | Ophthalmic | Solution/Drops | 018086 | 05/15/2019 |
| Tinidazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021618.pdf | Draft | Oral | Tablet | 021618 | 11/21/2019 |
| Tioconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tioconazole_vagcrm_20676_RC03-11.pdf | Draft | Vaginal | Ointment | 020676 | 03/31/2011 |
| Tiopronin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tiopronin_oral tablet_NDA 19569_RC05-17.pdf | Draft | Oral | Tablet | 019569 | 07/13/2017 |
| Tiopronin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211843.pdf | Draft | Oral | Tablet, Delayed Release | 211843 | 05/19/2022 |
| Tiotropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021395.pdf | Draft | Inhalation | Powder | 021395 | 11/16/2023 |
| Tiotropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021936.pdf | Draft | Inhalation | Spray, Metered | 021936 | 08/22/2024 |
| Tipiracil Hydrochloride; Trifluridine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207981.pdf | Draft | Oral | Tablet | 207981 | 11/21/2019 |
| Tipranavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tipranavir_cap_21814_RC11-07.pdf | Draft | Oral | Capsule | 021814 | 11/01/2007 |
| Tirbanibulin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213189.pdf | Draft | Topical | Ointment | 213189 | 10/21/2022 |
| Tirzepatide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215866.pdf | Draft | Subcutaneous | Solution | 215866 | 08/21/2023 |
| Tivozanib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212904.pdf | Draft | Oral | Capsule | 212904 | 11/17/2022 |
| Tizanidine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tizanidine_HCl_cap_21447_RC2-06.pdf | Final | Oral | Capsule | 021447 | 05/12/2008 |
| Tizanidine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tizanidine_HCl_tabs_20397_RC11-10.pdf | Draft | Oral | Tablet | 020397 | 11/26/2010 |
| Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_201688.pdf | Draft | Inhalation | Powder | 201688 | 05/16/2024 |
| 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 | 05/15/2019 |
| 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 | 05/15/2019 |
| Tofacitinib Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208246.pdf | Draft | Oral | Tablet, Extended Release | 208246 | 05/19/2021 |
| Tofersen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215887.pdf | Draft | Intrathecal | Solution | 215887 | 08/22/2024 |
| Tolcapone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tolcapone_Oral tablet_020697_RC06-15.pdf | Draft | Oral | Tablet | 020697 | 06/24/2015 |
| Tolterodine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tolterodine_Tartrate_tab_20771_RC3-05.pdf | Final | Oral | Tablet | 020771 | 05/12/2008 |
| Tolterodine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tolterodine_ER_Capsules_021228_RC09-12.pdf | Draft | Oral | Capsule, Extended Release | 021228 | 09/19/2012 |
| Tolvaptan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204441.pdf | Draft | Oral | Tablet | 204441 | 03/02/2020 |
| Tolvaptan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tolvaptan_tab_22275_RC03-12.pdf | Draft | Oral | Tablet | 022275 | 03/28/2012 |
| Topiramate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topiramate_tab_20505_RV06-13.pdf | Draft | Oral | Tablet | 020505 | 06/19/2013 |
| Topiramate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topiramate_ ER Cap_205122_RC03-15.pdf | Draft | Oral | Capsule, Extended Release | 205122 | 03/06/2015 |
| Topiramate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topiramate_ERcap_201635_RC03-15.pdf | Draft | Oral | Capsule, Extended Release | 201635 | 03/06/2015 |
| Topiramate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topiramate_cap_20844_RV06-13.pdf | Draft | Oral | Capsule | 020844 | 06/19/2013 |
| Topotecan Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Topotecan_caps_20981_RC03-11.pdf | Draft | Oral | Capsule | 020981 | 03/31/2011 |
| Toremifene Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Toremifene_Citrate_tab_20497_RC4-09.pdf | Final | Oral | Tablet | 020497 | 10/28/2011 |
| Torsemide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020136.pdf | Draft | Oral | Tablet | 020136 | 05/19/2022 |
| Torsemide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213218.pdf | Draft | Oral | Tablet | 213218 | 05/19/2022 |
| 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 | 09/18/2015 |
| Tramadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021692.pdf | Draft | Oral | Tablet, Extended Release | 021692 | 08/22/2024 |
| Tramadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tramadol_HCl_tab_20281_RC7-03.pdf | Final | Oral | Tablet | 020281 | 05/12/2008 |
| Trametinib Dimethyl Sulfoxide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204114.pdf | Draft | Oral | Tablet | 204114 | 05/19/2022 |
| Trandolapril | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trandolapril_tab_20528_RC12-05.pdf | Final | Oral | Tablet | 020528 | 05/12/2008 |
| Trandolapril; Verapamil Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trandolapril;_Verapamil_ERtab_20591_RC12-08.pdf | Draft | Oral | Tablet, Extended Release | 020591 | 12/20/2008 |
| Tranexamic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tranexamic_Acid_22430_RC12-10.pdf | Draft | Oral | Tablet | 022430 | 03/31/2011 |
| Tranylcypromine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tranylcypromine_sulfate_tab_12342_RC02-14.pdf | Draft | Oral | Tablet | 012342 | 04/01/2014 |
| Trazodone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trazodone_HCl_tab_71196_71258_RC2-10.pdf | Draft | Oral | Tablet | 018207 | 02/25/2010 |
| Trazodone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trazodone_HCl_ERtab_22411_RC09-12.pdf | Draft | Oral | Tablet, Extended Release | 022411 | 09/19/2012 |
| 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 | 02/22/2019 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016921.pdf | Draft | Topical | Solution | 016921 | 09/16/2019 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin Topical Cream ANDA 090098 RV Feb 2019.pdf | Draft | Topical | Cream | 090098 | 02/22/2019 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017579.pdf | Draft | Topical | Gel | 017579 | 10/21/2022 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022070.pdf | Draft | Topical | Gel | 022070 | 10/21/2022 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017955.pdf | Draft | Topical | Gel | 017955 | 10/21/2022 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020475.pdf | Draft | Topical | Gel | 020475 | 05/16/2024 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021108.pdf | Draft | Topical | Cream | 021108 | 06/03/2020 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019963.pdf | Draft | Topical | Cream | 019963 | 06/03/2020 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019049.pdf | Draft | Topical | Cream | 019049 | 06/03/2020 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017522.pdf | Draft | Topical | Cream | 017522 | 06/03/2020 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017340.pdf | Draft | Topical | Cream | 017340 | 06/03/2020 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209353.pdf | Draft | Topical | Lotion | 209353 | 06/03/2020 |
| Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Tretinoin_Caps_77684_RC09-10.pdf | Draft | Oral | Capsule | 020438 | 09/30/2010 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020468.pdf | Draft | Nasal | Spray, Metered | 020468 | 08/21/2023 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_dental paste_NDA 012097_RV11-17.pdf | Draft | Dental | Paste | 012097 | 02/08/2018 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211950.pdf | Draft | Injection | Suspension | 211950 | 02/16/2023 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012041.pdf | Draft | Injection | Injectable | 012041 014901 | 11/08/2021 |
| Triamcinolone acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamcinolone acetonide_intravitreal injectable_NDA 022048_RC07-18.pdf | Draft | Intravitreal | Injectable | 022048 | 07/20/2018 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011601.pdf | Draft | Topical | Cream | 011601 | 10/21/2022 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011600.pdf | Draft | Topical | Ointment | 087385 | 10/21/2022 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011600-Oin-0.05P.pdf | Draft | Topical | Ointment 0.05% | 089595 | 10/21/2022 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011602.pdf | Draft | Topical | Lotion | 011602 | 10/21/2022 |
| Triamcinolone Acetonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208845.pdf | Draft | Intra-Articular | For Suspension, Extended Release | 208845 | 11/17/2022 |
| Triamterene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triamterene_Oral capsule_NDA 013174_RV Oct 2018.pdf | Draft | Oral | Capsule | 013174 | 11/28/2018 |
| Triazolam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Triazolam_tabs_17892_RC08-10.pdf | Draft | Oral | Tablet | 017892 | 08/30/2010 |
| Triclabendazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208711.pdf | Draft | Oral | Tablet | 208711 | 06/03/2020 |
| Trientine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trientine_HCl_caps_019194_RC06-13.pdf | Draft | Oral | Capsule | 019194 | 06/19/2013 |
| Trifarotene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211527.pdf | Draft | Topical | Cream | 211527 | 05/19/2021 |
| Triheptanoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213687.pdf | Draft | Oral | Liquid | 213687 | 05/19/2022 |
| Trilaciclib Dihydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214200.pdf | Draft | Intravenous | Powder | 214200 | 11/17/2022 |
| Trimethoprim | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trimethoprim_tabs_71259_18679_RC2-10.pdf | Draft | Oral | Tablet | 018679 | 02/25/2010 |
| Trimipramine Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Trimipramine maleate_oral capsule_ 016792_RC09-15.pdf | Draft | Oral | Capsule | 016792 | 09/18/2015 |
| 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 | 02/01/2014 |
| Trofinetide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217026.pdf | Draft | Oral | Solution | 217026 | 08/22/2024 |
| Trospium Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022103.pdf | Draft | Oral | Capsule, Extended Release | 022103 | 08/22/2024 |
| 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 | 05/16/2017 |
| Tucatinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213411.pdf | Draft | Oral | Tablet | 213411 | 11/08/2021 |
Newly Added Guidances since August 22, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Air Polymer-Type A | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212279.pdf | Draft | Intrauterine | Foam | 212279 | 08/22/2024 |
| Fezolinetant | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216578.pdf | Draft | Oral | Tablet | 216578 | 08/22/2024 |
| Heparin Sodium; Taurolidine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214520.pdf | Draft | N/A | Solution | 214520 | 08/22/2024 |
| Leniolisib Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217759.pdf | Draft | Oral | Tablet | 217759 | 08/22/2024 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217722.pdf | Draft | Nasal | Spray, Metered | 217722 | 08/22/2024 |
| Nedosiran Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215842.pdf | Draft | Injection | Solution | 215842 | 08/22/2024 |
| Nirmatrelvir; Ritonavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217188.pdf | Draft | Oral | Tablet; Tablet | 217188 | 08/22/2024 |
| Pegcetacoplan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217171.pdf | Draft | Intravitreal | Solution | 217171 | 08/22/2024 |
| Risperidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212849.pdf | Draft | Intramuscular | For Suspension, Extended Release | 212849 | 08/22/2024 |
| Sotagliflozin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216203.pdf | Draft | Oral | Tablet | 216203 | 08/22/2024 |
| Tafluprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202514.pdf | Draft | Ophthalmic | Solution, Drops | 202514 | 08/22/2024 |
| Teriparatide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021318.pdf | Draft | Subcutaneous | Solution | 021318 | 08/22/2024 |
| Tofersen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215887.pdf | Draft | Intrathecal | Solution | 215887 | 08/22/2024 |
| Trofinetide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_217026.pdf | Draft | Oral | Solution | 217026 | 08/22/2024 |
Newly Revised Guidances since August 22, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Albuterol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020503.pdf | Draft | Inhalation | Aerosol, Metered | 020503 020983 021457 | 08/22/2024 |
| Albuterol Sulfate; Ipratropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf | Draft | Inhalation | Spray, Metered | 021747 | 08/22/2024 |
| Apalutamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210951.pdf | Draft | Oral | Tablet | 210951 | 08/22/2024 |
| Azelaic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020428.pdf | Draft | Topical | Cream | 020428 | 08/22/2024 |
| Bempedoic Acid; Ezetimibe | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211617.pdf | Draft | Oral | Tablet | 211617 | 08/22/2024 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf | Draft | Inhalation | Powder, Metered | 021949 | 08/22/2024 |
| Bupropion Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020358.pdf | Draft | Oral | Tablet, Extended Release | 020358 020711 | 08/22/2024 |
| Carvedilol Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022012.pdf | Draft | Oral | Capsule, Extended Release | 022012 | 08/22/2024 |
| Ciprofloxacin Hydrochloride; Hydrocortisone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020805.pdf | Draft | Otic | Suspension/Drops | 020805 | 08/22/2024 |
| Ciprofloxacin; Dexamethasone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021537.pdf | Draft | Otic | Suspension/Drops | 021537 | 08/22/2024 |
| Cladribine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022561.pdf | Draft | Oral | Tablet | 022561 | 08/22/2024 |
| Dalfampridine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022250.pdf | Draft | Oral | Tablet, Extended Release | 022250 | 08/22/2024 |
| Dapagliflozin; Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205649.pdf | Draft | Oral | Tablet, Extended Release | 205649 | 08/22/2024 |
| Donepezil Hydrochloride; Memantine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206439.pdf | Draft | Oral | Capsule, Extended Release | 206439 | 08/22/2024 |
| Fentanyl Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022569.pdf | Draft | Nasal | Spray, Metered | 022569 | 08/22/2024 |
| Ferric Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf | Draft | Oral | Tablet | 205874 | 08/22/2024 |
| Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf | Draft | Inhalation | Powder | 209482 | 08/22/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021433.pdf | Draft | Inhalation | Aerosol, Metered | 021433 | 08/22/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf | Draft | Inhalation | Powder | 020833 | 08/22/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf | Draft | Inhalation | Powder | 208798 | 08/22/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf | Draft | Inhalation | Powder | 208799 | 08/22/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021254.pdf | Draft | Inhalation | Aerosol, Metered | 021254 | 08/22/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf | Draft | Inhalation | Powder | 021077 | 08/22/2024 |
| Halobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019968.pdf | Draft | Topical | Ointment | 019968 | 08/22/2024 |
| Hydrochlorothiazide; Metoprolol Succinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021956.pdf | Draft | Oral | Tablet, Extended Release | 021956 | 08/22/2024 |
| Hydromorphone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021217.pdf | Draft | Oral | Tablet, Extended Release | 021217 | 08/22/2024 |
| Ibrutinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210563.pdf | Draft | Oral | Tablet | 210563 | 08/22/2024 |
| Levalbuterol Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021730.pdf | Draft | Inhalation | Aerosol, Metered | 021730 | 08/22/2024 |
| Levomilnacipran Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204168.pdf | Draft | Oral | Capsule, Extended Release | 204168 | 08/22/2024 |
| Memantine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022525.pdf | Draft | Oral | Capsule, Extended Release | 022525 | 08/22/2024 |
| Metformin Hydrochloride; Sitagliptin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202270.pdf | Draft | Oral | Tablet, Extended Release | 202270 | 08/22/2024 |
| Metformin Hydrochloride;Saxagliptin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200678.pdf | Draft | Oral | Tablet, Extended Release | 200678 | 08/22/2024 |
| Mometasone Furoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf | Draft | Inhalation | Powder | 021067 | 08/22/2024 |
| Morphine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019516.pdf | Draft | Oral | Tablet, Extended Release | 019516 | 08/22/2024 |
| Morphine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021260.pdf | Draft | Oral | Capsule, Extended Release | 079040 | 08/22/2024 |
| Morphine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020616.pdf | Draft | Oral | Capsule, Extended Release | 020616 | 08/22/2024 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208411.pdf | Draft | Nasal | Spray, Metered | 208411 | 08/22/2024 |
| Olodaterol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf | Draft | Inhalation | Spray, Metered | 203108 | 08/22/2024 |
| Olodaterol Hydrochloride; Tiotropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206756.pdf | Draft | Inhalation | Spray, Metered | 206756 | 08/22/2024 |
| Oxcarbazepine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202810.pdf | Draft | Oral | Tablet, Extended Release | 202810 | 08/22/2024 |
| Oxymorphone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021610.pdf | Draft | Oral | Tablet, Extended Release | 021610 | 08/22/2024 |
| Phentermine Hydrochloride;Topiramate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022580.pdf | Draft | Oral | Capsule, Extended Release | 022580 | 08/22/2024 |
| Posaconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205053.pdf | Draft | Oral | Tablet, Delayed Release | 205053 | 08/22/2024 |
| Pramipexole Dihydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022421.pdf | Draft | Oral | Tablet, Extended Release | 022421 | 08/22/2024 |
| Progesterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022057.pdf | Draft | Vaginal | Insert | 022057 | 08/22/2024 |
| Promethazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010926.pdf | Draft | Rectal | Suppository | 010926 | 08/22/2024 |
| Quetiapine Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022047.pdf | Draft | Oral | Tablet, Extended Release | 022047 | 08/22/2024 |
| Tacrolimus | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206406.pdf | Draft | Oral | Tablet, Extended Release | 206406 | 08/22/2024 |
| Tapentadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200533.pdf | Draft | Oral | Tablet, Extended Release | 200533 | 08/22/2024 |
| Tiotropium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021936.pdf | Draft | Inhalation | Spray, Metered | 021936 | 08/22/2024 |
| Tramadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021692.pdf | Draft | Oral | Tablet, Extended Release | 021692 | 08/22/2024 |
| Trospium Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022103.pdf | Draft | Oral | Capsule, Extended Release | 022103 | 08/22/2024 |
| Venlafaxine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022104.pdf | Draft | Oral | Tablet, Extended Release | 022104 | 08/22/2024 |
| Verteporfin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021119.pdf | Draft | Injection | Injectable | 021119 | 08/22/2024 |