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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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: 2187
189 record(s) found for 'D'
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Dabigatran Etexilate Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dabigatran etexilate mesylate_oral capsule_NDA 022512_RV05-17.pdf | Draft | Oral | Capsule | 022512 | 07/13/2017 |
| Dabrafenib Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dabrafenib mesylate_oral capsule_202806_RC06-15.pdf | Draft | Oral | Capsule | 202806 | 06/24/2015 |
| Daclatasvir Dihydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Daclatasvir dihydrochloride_oral tablet_NDA 206843_RV11-17.pdf | Draft | Oral | Tablet | 206843 | 02/08/2018 |
| Dacomitinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211288.pdf | Draft | Oral | Tablet | 211288 | 03/02/2020 |
| Dalfampridine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dalfampridine_ERtab_22250_RC03-12.pdf | Draft | Oral | Tablet, Extended Release | 022250 | 03/28/2012 |
| Dalteparin Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dalteparin_Inj_20287_RC09-12.pdf | Draft | Subcutaneous | Injectable | 020287 | 09/19/2012 |
| Danazol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Danazol_cap_74582_RC10-05.pdf | Final | Oral | Capsule | 074582 | 05/01/2008 |
| Dantrolene Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205579.pdf | Draft | Intravenous | For Suspension | 205579 | 08/02/2022 |
| Dantrolene Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017443.pdf | Draft | Oral | Capsule | 017443 | 09/16/2019 |
| Dapagliflozin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202293.pdf | Draft | Oral | Tablet | 202293 | 06/03/2020 |
| Dapagliflozin; Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205649.pdf | Draft | Oral | Tablet, Extended Release | 205649 | 03/02/2020 |
| Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210874.pdf | Draft | Oral | Tablet, Extended Release | 210874 | 03/02/2020 |
| Dapagliflozin; Saxagliptin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209091.pdf | Draft | Oral | Tablet | 209091 | 06/03/2020 |
| Dapsone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207154.pdf | Draft | Topical | Gel | 207154 | 02/15/2024 |
| Dapsone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dapsone_oral tablet_ANDA 086842_Final 08-17.pdf | Final | Oral | Tablet | 086841 086842 | 08/04/2017 |
| Dapsone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021794.pdf | Draft | Topical | Gel | 021794 | 02/15/2024 |
| Daptomycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/DAPTOMYCIN IV infusion powder NDA 209949 & NDA 208385 Page Feb 2019.pdf | Draft | IV Infusion | Powder | 209949 208385 | 02/22/2019 |
| Daridorexant Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214985.pdf | Draft | Oral | Tablet | 214985 | 08/21/2023 |
| Darifenacin Hydrobromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Darifenacin_HBr_ERtab_21513_RC8-05.pdf | Final | Oral | Tablet, Extended Release | 021513 | 05/12/2008 |
| Darolutamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212099.pdf | Draft | Oral | Tablet | 212099 | 08/28/2020 |
| Darunavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Darunavir_Ethanolate_tab_21976_RV04-13.pdf | Draft | Oral | Tablet | 021976 | 04/05/2013 |
| Darunavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Darunavir_ethanolate_susp_202895_RC12-14.pdf | Draft | Oral | Suspension | 202895 | 12/29/2014 |
| Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/DasabuvirNa; Ombitasvir; Paritaprevir; Ritonavir_RC05-17.pdf | Draft | Oral | Tablet, Extended Release | 208624 | 07/13/2017 |
| Dasabuvir Sodium;Ombitasvir;Paritaprevir;Ritonavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Obitasvir_paritaprevir_ritonavir_dasabuvir_oral tablet_206619_RC09-15.pdf | Draft | Oral | Tablet, Tablet | 206619 | 09/18/2015 |
| Dasatinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021986.pdf | Draft | Oral | Tablet | 021986 | 05/19/2021 |
| Dasiglucagon Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214231.pdf | Draft | Subcutaneous | Solution | 214231 | 08/02/2022 |
| Daunorubicin Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050704.pdf | Draft | Injection | Injectable, Liposomal | 050704 | 11/17/2022 |
| Deferasirox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_oral tablet_RLD 206910_RC04-16.pdf | Draft | Oral | Tablet | 206910 | 04/14/2016 |
| Deferasirox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_susp_21882_RC5-06.pdf | Final | Oral | Tablet, For Suspension | 021882 | 05/12/2008 |
| Deferasirox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_draft_Oral gran_RLD 207968_RC07-18.pdf | Draft | Oral | Granule | 207968 | 07/20/2018 |
| Deferiprone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212269.pdf | Draft | Oral | Tablet | 212269 | 11/17/2022 |
| Deferiprone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021825.pdf | Draft | Oral | Tablet | 021825 | 11/17/2022 |
| Defibrotide Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208114.pdf | Draft | Intravenous | Solution | 208114 | 05/18/2023 |
| Deflazacort | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deflazacort_oral suspension_NDA 208685_RC08-17.pdf | Draft | Oral | Suspension | 208685 | 10/19/2017 |
| Deflazacort | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deflazacort_oral tablet_NDA 208684_RC08-17.pdf | Draft | Oral | Tablet | 208684 | 10/19/2017 |
| Degarelix Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022201.pdf | Draft | Subcutaneous | Powder | 022201 | 03/24/2021 |
| Delafloxacin meglumine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Delafloxacin meglumine_draft_Oral tab_RLD 208610_RC09-18.pdf | Draft | Oral | Tablet | 208610 | 09/13/2018 |
| Delavirdine Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Delavirdine_Mesylate 20705_RC11-07.pdf | Draft | Oral | Tablet | 020705 | 11/01/2007 |
| Demeclocycline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Demeclocycline_HCl_tab_50261_RC10-08.pdf | Draft | Oral | Tablet | 050261 | 10/01/2008 |
| Desipramine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desipramine HCl_ oral tablet_ RLD 14399_Final 08-17.pdf | Final | Oral | Tablet | 014399 | 08/04/2017 |
| Desloratadine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desloratadine_tab_21165_RC10-05.pdf | Final | Oral | Tablet | 021165 | 05/12/2008 |
| Desloratadine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021312.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021312 | 11/08/2021 |
| Desloratadine; Pseudoephedrine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desloratadine_Pseudoephedrine_Oral_Extended_Release_Tablet_NDA_021313_PSG_Page_RC_May_2019.pdf | Draft | Oral | Tablet, Extended Release | 021313 | 05/15/2019 |
| Desmopressin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desmopressin acetate Sublingual Tablets NDA 022517 PSG Page RC May 2019.pdf | Draft | Sublingual | Tablet | 022517 | 05/15/2019 |
| Desmopressin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desmopressin acetate_ oral tablet_ RLD19955_Final 08-17.pdf | Final | Oral | Tablet | 019955 | 08/04/2017 |
| Desogestrel; Ethinyl Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desogestrel;_Ethiny_ Estradiol_tab_20301_RC4-09.pdf | Draft | Oral | Tablet | 020301 | 03/01/2010 |
| Desogestrel; Ethinyl Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desogestrel;_Ethinyl_Estradiol_(Cyclessa)_21090_RC3-09.pdf | Draft | Oral | Tablet | 021090 | 03/01/2009 |
| Desogestrel; Ethinyl Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desogestrel;_EE _(mircette)_tab_20713_RC8-08.pdf | Draft | Oral | Tablet | 020713 | 07/09/2009 |
| Desonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical ointment_RLD 017426_RC09-16.pdf | Draft | Topical | Ointment | 017426 | 10/04/2016 |
| Desonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical cream_RLD 017010_RC01-16.pdf | Draft | Topical | Cream | 017010 | 01/27/2016 |
| Desonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical lotion_RLD 072354_RC01-16.pdf | Draft | Topical | Lotion | 072354 | 01/27/2016 |
| Desonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_draft_Topical gel_RLD 021844_RC09-18.pdf | Draft | Topical | Gel | 021844 | 09/13/2018 |
| Desonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021978.pdf | Draft | Topical | Aerosol, Foam | 021978 | 11/18/2020 |
| Desoximetasone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desoximetasone_topical spray 0.25_204141_RC03-15.pdf | Draft | Topical | Spray | 204141 | 03/06/2015 |
| Desoximetasone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desoximetasone_cream_073210_073193_RC02-14.pdf | Draft | Topical | Cream | 017856 018309 | 04/01/2014 |
| Desoximetasone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desoximetasone_ointment_18594_74286_RC02-14.pdf | Draft | Topical | Ointment | 018594 018763 | 04/01/2014 |
| Desvenlafaxine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204683.pdf | Draft | Oral | Tablet, Extended Release | 204683 | 06/03/2020 |
| Desvenlafaxine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204150.pdf | Draft | Oral | Tablet, Extended Release | 204150 | 06/03/2020 |
| Desvenlafaxine Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205583.pdf | Draft | Oral | Tablet, Extended Release | 205583 | 06/03/2020 |
| Desvenlafaxine Succinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021992.pdf | Draft | Oral | Tablet, Extended Release | 021992 | 06/03/2020 |
| Deucravacitinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214958.pdf | Draft | Oral | Tablet | 214958 | 11/16/2023 |
| Deutetrabenazine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216354.pdf | Draft | Oral | Tablet, Extended Release | 216354 | 11/16/2023 |
| Deutetrabenazine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deutetrabenazine_draft_Oral tab_RLD 208082_RC09-18.pdf | Draft | Oral | Tablet | 208082 | 09/13/2018 |
| Dexamethasone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone Oral Concentrate Solution ANDA 088252 RC Feb 2019.pdf | Draft | Oral | Concentrate | 088252 | 02/22/2019 |
| Dexamethasone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone_tabs_88316_84612_87916_88306_84610_84613_84611_RC06-11.pdf | Draft | Oral | Tablet | 011664 | 06/30/2011 |
| Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050023.pdf | Draft | Ophthalmic | Suspension/Drops | 050023 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050818.pdf | Draft | Ophthalmic | Suspension/Drops | 050818 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050616.pdf | Draft | Ophthalmic | Ointment | 050616 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050592.pdf | Draft | Ophthalmic | Suspension/Drops | 050592 | 02/15/2024 |
| Dexbrompheniramine Maleate; Pseudoephedrine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexbrompheniramine maleate Pseudoephedrine sulfate_078648_RC06-15.pdf | Draft | Oral | Tablet, Extended Release | 013483 | 06/24/2015 |
| Dexlansoprazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexlansoprazole_orally disintegrating DR tablet_NDA 208056_RV11-17.pdf | Draft | Oral | Tablet, Orally Disintegrating, Delayed Release | 208056 | 02/08/2018 |
| Dexlansoprazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexlansoprazole_oral DR capsule_NDA 022287_RV11-17.pdf | Draft | Oral | Capsule, Delayed Release | 022287 | 02/08/2018 |
| Dexmethylphenidate Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexmethylphenidate_tab_21278_RC2-08.pdf | Draft | Oral | Tablet | 021278 | 04/06/2008 |
| Dexmethylphenidate Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexmethylphenidate HCL_Oral ER cap_21802_RV03-15.pdf | Draft | Oral | Capsule, Extended Release | 021802 | 03/06/2015 |
| Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212994.pdf | Draft | Oral | Capsule | 212994 | 02/16/2023 |
| Dextroamphetamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215401.pdf | Draft | Transdermal | System | 215401 | 11/16/2023 |
| Dextroamphetamine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextroamphetamine Sulfate_Oral ER Cap_017078_RV03-15.pdf | Draft | Oral | Capsule, Extended Release | 017078 | 03/06/2015 |
| Dextroamphetamine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextroamphetamine sulfate_oral tablet_ANDA 040361_RC05-17.pdf | Draft | Oral | Tablet | 040361 | 07/13/2017 |
| Dextromethorphan Hydrobromide; Guaifenesin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextromethorphan_Hydrobromide;_Guaifenesin_ERtab_21620_RC12-08.pdf | Draft | Oral | Tablet, Extended Release | 021620 | 12/20/2008 |
| Dextromethorphan Hydrobromide; Quinidine Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextromethorphan_Quinidine_cap_021879_RV04-13.pdf | Draft | Oral | Capsule | 021879 | 04/05/2013 |
| Dextromethorphan Polistirex | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextromethorphan_Polistirex_ERsusp_18658_RC10-05.pdf | Final | Oral | Suspension, Extended Release | 018658 | 05/12/2008 |
| Diazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazepam_Rectal_gel_20648_RC08-10.pdf | Draft | Rectal | Gel | 020648 | 07/28/2010 |
| Diazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211635.pdf | Draft | Nasal | Spray | 211635 | 02/15/2024 |
| Diazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazepam_draft_Oral tab_RLD 013263_RC09-18.pdf | Draft | Oral | Tablet | 013263 | 09/13/2018 |
| Diazoxide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazoxide_oral_suspension_17453_RC02-14.pdf | Draft | Oral | Suspension | 017453 | 04/01/2014 |
| Dichlorphenamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dichlorphenamide_Oral_tablets_NDA_011366_RC_Oct_2018.pdf | Draft | Oral | Tablet | 011366 | 11/28/2018 |
| Diclofenac | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_oral capsule_204592_RC03-15.pdf | Draft | Oral | Capsule | 204592 | 03/06/2015 |
| Diclofenac Epolamine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021234.pdf | Draft | Topical | System | 021234 | 08/21/2023 |
| Diclofenac Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Potassium_cap_22202_RC4-11.pdf | Draft | Oral | Capsule | 022202 | 04/26/2011 |
| Diclofenac Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020142.pdf | Draft | Oral | Tablet | 020142 | 11/08/2021 |
| Diclofenac Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac sodium_topical solution_NDA 204623_RC05-17.pdf | Draft | Topical | Solution | 204623 | 07/13/2017 |
| Diclofenac Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_ Sodium_sol_top_20947_RC04-11.pdf | Draft | Topical | Solution | 020947 | 06/30/2011 |
| Diclofenac Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022122.pdf | Draft | Topical | Gel | 022122 | 10/21/2022 |
| Diclofenac Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021005.pdf | Draft | Topical | Gel | 021005 | 10/21/2022 |
| Diclofenac Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Sodium_DRtab_19201_74376_RC10-09.pdf | Draft | Oral | Tablet, Delayed Release | 019201 | 10/01/2009 |
| Diclofenac Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Sodium_ERtab_20254_RC10-09.pdf | Draft | Oral | Tablet, Extended Release | 020254 | 10/01/2009 |
| Diclofenac Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac sodium_ophthalmic solution_NDA 020037_RV08-17.pdf | Draft | Ophthalmic | Solution/Drops | 020037 | 10/19/2017 |
| Diclofenac Sodium; Misoprostol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Sodium;_Misoprostol_ DRtab_20607_ RC2-02.pdf | Draft | Oral | Tablet, Delayed Release | 020607 | 12/23/2009 |
| Dicloxacillin Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dicloxacillin_cap_62286_RC6-05.pdf | Final | Oral | Capsule | 061454 | 05/01/2008 |
| Dicyclomine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_007409-Tab.pdf | Draft | Oral | Tablet | 007409 | 11/08/2021 |
| Dicyclomine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_007409-Cap.pdf | Draft | Oral | Capsule | 007409 | 02/17/2022 |
| Didanosine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Didanosine_tab_for_susp_77275_RV06-13.pdf | Draft | Oral | Tablet, For Suspension | 077275 | 06/19/2013 |
| Didanosine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021183.pdf | Draft | Oral | Capsule, Delayed Release Pellets | 021183 | 11/21/2019 |
| Dienogest;Estradiol Valerate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dienogest;_Estradiol_Valerate_tab_22252_RC12-10.pdf | Draft | Oral | Tablet | 022252 | 12/23/2010 |
| Diethylpropion Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diethylpropion_ERtab_ 12546_RC12-09.pdf | Draft | Oral | Tablet, Extended Release | 012546 | 12/17/2009 |
| Difelikefalin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214916.pdf | Draft | Intravenous | Solution | 214916 | 05/18/2023 |
| Diflorasone Diacetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflorasone_Ointment_075331_RC07-14.pdf | Draft | Topical | Ointment | 019260 | 07/22/2014 |
| Diflorasone Diacetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflorasone diacetate_topical cream_RLD 075508_RC01-16.pdf | Draft | Topical | Cream | 075508 | 01/27/2016 |
| Diflorasone Diacetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflorasone diacetate_topical cream_RLD 076263_RC01-16.pdf | Draft | Topical | Cream | 076263 | 01/27/2016 |
| Diflunisal | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflunisal_ oral tablet_ RLD18445_Final 08-17.pdf | Final | Oral | Tablet | 018445 | 08/04/2017 |
| Difluprednate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Difluprednate_ophthalmic emulsion_RLD 022212_RV02-17.pdf | Draft | Ophthalmic | Emulsion | 022212 | 02/14/2017 |
| Digoxin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Digoxin_oral tablet_NDA 020405_RV08-17.pdf | Draft | Oral | Tablet | 020405 | 08/29/2017 |
| Dihydroergotamine Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020148.pdf | Draft | Nasal | Spray, Metered | 020148 | 06/03/2020 |
| Dihydroergotamine Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213436.pdf | Draft | Nasal | Spray, Metered | 213436 | 02/16/2023 |
| Diltiazem Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018602.pdf | Draft | Oral | Tablet | 018602 | 03/02/2020 |
| Diltiazem Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021392.pdf | Draft | Oral | Tablet, Extended Release | 021392 | 06/03/2020 |
| Diltiazem Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020401.pdf | Draft | Oral | Capsule, Extended Release | 020401 | 06/03/2020 |
| Diltiazem Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020092.pdf | Draft | Oral | Capsule, Extended Release | 020092 | 06/03/2020 |
| Diltiazem Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020062.pdf | Draft | Oral | Capsule, Extended Release | 020062 | 06/03/2020 |
| Diltiazem Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019471.pdf | Draft | Oral | Capsule, Extended Release | 019471 | 06/03/2020 |
| Dimethyl Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dimethyl fumarate_DRcap_204063_RC07-14.pdf | Draft | Oral | Capsule, Delayed Release | 204063 | 07/22/2014 |
| Dinoprostone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dinoprostone_Supp_Vag_017810_RC06-12.pdf | Draft | Vaginal | Suppository | 017810 | 06/14/2012 |
| Dinoprostone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dinoprostone_insert_vag_ER_20411_RC11-11.pdf | Draft | Vaginal | Insert, Extended Release | 020411 | 11/29/2011 |
| Dinoprostone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dinoprostone_gel_endocx_19617_RC9-11.pdf | Draft | Endocervical | Gel | 019617 | 09/29/2011 |
| Diphenhydramine Citrate; Ibuprofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021394.pdf | Draft | Oral | Tablet | 021394 | 09/16/2019 |
| Diphenhydramine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diphenhydramine HCl_ oral capsule_ ANDA 80738_Final 08-17c.pdf | Final | Oral | Capsule | 080738 | 08/04/2017 |
| Diphenhydramine Hydrochloride; Ibuprofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diphenhydramine_HCl_Ibuprofen_caps_21393_RC06-12_OTC.pdf | Draft | Oral | Capsule | 021393 | 06/14/2012 |
| Diphenhydramine Hydrochloride; Naproxen Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diphenhydramine HCL_Naproxen Sodium_Oral tab_205352_RC03-15.pdf | Draft | Oral | Tablet | 205352 | 03/06/2015 |
| Dipyridamole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dipyridamole_ oral tablet_ RLD 12836_Final 08-17.pdf | Final | Oral | Tablet | 012836 | 08/04/2017 |
| Diroximel Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211855.pdf | Draft | Oral | Capsule, Delayed Release | 211855 | 08/28/2020 |
| Disopyramide Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017447.pdf | Draft | Oral | Capsule | 017447 | 11/21/2019 |
| Disopyramide Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Disopyramide_Phosphate_ERcap_18655_RC10-08.pdf | Draft | Oral | Capsule, Extended Release | 018655 | 10/01/2008 |
| Disulfiram | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Disulfiram_ oral tablet_ RLD 007883_Final 08-17.pdf | Final | Oral | Tablet | 007883 | 08/04/2017 |
| Divalproex Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Divalproex sodium__oral DR tablet_RLD 018723_RV12-16.pdf | Draft | Oral | Tablet, Delayed Release | 018723 | 12/22/2016 |
| Divalproex Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Divalproex sodium_oral DR pellets capsule_RLD 019680_RV12-16.pdf | Draft | Oral | Capsule, Delayed Release Pellets | 019680 | 12/22/2016 |
| Divalproex Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Divalproex sodium__oral ER tablet_RLD 21168_RV12-16.pdf | Draft | Oral | Tablet, Extended Release | 021168 | 12/22/2016 |
| Docosanol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020941.pdf | Draft | Topical | Cream | 020941 | 10/21/2022 |
| Dofetilide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dofetilide_cap_20931_RC10-05.pdf | Final | Oral | Capsule | 020931 | 05/12/2008 |
| Dolasetron Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dolasetron_Mesylate_tab_20623_RC5-10.pdf | Draft | Oral | Tablet | 020623 | 05/20/2010 |
| Dolutegravir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204790.pdf | Draft | Oral | Tablet | 204790 | 08/28/2020 |
| Dolutegravir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213983.pdf | Draft | Oral | Tablet, For Suspension | 213983 | 02/17/2022 |
| Dolutegravir Sodium; Lamivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211994.pdf | Draft | Oral | Tablet | 211994 | 06/03/2020 |
| Dolutegravir Sodium; Rilpivirine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210192.pdf | Draft | Oral | Tablet | 210192 | 08/28/2020 |
| Donepezil Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021720.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021720 | 11/08/2021 |
| Donepezil Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212304.pdf | Draft | Transdermal | System | 212304 | 02/16/2023 |
| Donepezil Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil HCl_Oral Tablet_RLD 22568_Final 08-17.pdf | Final | Oral | Tablet | 022568 | 08/04/2017 |
| Donepezil Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil_HCl_tab_20690_RC10-05.pdf | Draft | Oral | Tablet | 020690 | 04/20/2010 |
| Donepezil Hydrochloride;Memantine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil Hydrochloride; Memantine Hydrochloride_draft_Oral cap ER_RLD 206439_RC07-18.pdf | Draft | Oral | Capsule | 206439 | 07/20/2018 |
| Doravirine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210806.pdf | Draft | Oral | Tablet | 210806 | 03/02/2020 |
| Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210807.pdf | Draft | Oral | Tablet | 210807 | 03/02/2020 |
| Dorzolamide Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/DORZOLAMIDE HYDROCHLORIDE_ophthalmic solution_NDA 020408_RV07-17.pdf | Draft | Ophthalmic | Solution/Drops | 020408 | 07/13/2017 |
| Doxazosin Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxazosin mesylate_Oral tablet_RLD 19668_Final 08-17.pdf | Final | Oral | Tablet | 019668 | 08/04/2017 |
| Doxazosin Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxazosin_Mesylate_ERtab_21269_RC9-06.pdf | Final | Oral | Tablet, Extended Release | 021269 | 05/12/2008 |
| Doxepin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022036.pdf | Draft | Oral | Tablet | 022036 | 02/15/2024 |
| Doxepin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016798.pdf | Draft | Oral | Capsule | 016798 | 05/18/2023 |
| Doxepin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020126.pdf | Draft | Topical | Cream | 020126 | 10/21/2022 |
| Doxercalciferol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxercalciferol_oral capsule_RLD 20862_Final 08-17.pdf | Final | Oral | Capsule | 020862 | 08/04/2017 |
| Doxorubicin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050718.pdf | Draft | Injection | Injectable, Liposomal | 050718 | 05/19/2022 |
| Doxycycline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_Capsule_050641_RC07-14.pdf | Draft | Oral | Capsule | 050641 | 07/22/2014 |
| Doxycycline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_Capsule_065055_RC07-14.pdf | Draft | Oral | Capsule | 065055 | 07/22/2014 |
| Doxycycline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_ DRcap_50805_RC2-08.pdf | Draft | Oral | Capsule | 050805 | 04/06/2008 |
| Doxycycline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_tab_65070_RC10-05.pdf | Draft | Oral | Tablet | 065070 | 02/23/2008 |
| Doxycycline | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_susp_50006_RC8-08.pdf | Draft | Oral | Suspension | 050006 | 08/01/2008 |
| Doxycycline calcium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline Calcium Oral Suspension NDA 050480 RC Feb 2019.pdf | Draft | Oral Suspension | Suspension | 050480 | 02/22/2019 |
| Doxycycline Hyclate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050751.pdf | Draft | Periodontal | System, Extended Release | 050751 | 08/02/2022 |
| Doxycycline Hyclate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209844.pdf | Draft | Oral | Tablet | 209844 | 11/21/2019 |
| Doxycycline Hyclate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050533.pdf | Draft | Oral | Tablet | 050533 | 03/24/2021 |
| Doxycycline Hyclate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral capsule_RLD 208253_RC12-16.pdf | Draft | Oral | Capsule | 208253 | 12/22/2016 |
| Doxycycline Hyclate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hydate_oral tablet_205931_RC06-15.pdf | Draft | Oral | Tablet | 205931 | 06/24/2015 |
| Doxycycline Hyclate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_Hyclate_cap_50007_RC7-08.pdf | Draft | Oral | Capsule | 050007 | 07/01/2008 |
| Doxycycline Hyclate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral DR tablet_NDA 050795_RV03-18.pdf | Draft | Oral | Tablet, Delayed Release | 050795 | 03/28/2018 |
| Doxycycline Hyclate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral tablet_NDA 050783_RC11-17.pdf | Draft | Oral | Tablet | 050783 | 02/08/2018 |
| Doxylamine Succinate; Pyridoxine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxylamine succinate_Pyridoxine HCl_DRtab_21876_RC07-14.pdf | Draft | Oral | Tablet, Delayed Release | 021876 | 07/22/2014 |
| Doxylamine succinate; Pyridoxine hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxylamine succinate and pyridoxine hydrochloride oral ER tablet NDA 209661 RC Feb 2019.pdf | Draft | Oral | Capsule, Extended Release | 209661 | 02/22/2019 |
| Dronabinol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dronabinol_cap_18651_RV02-14.pdf | Draft | Oral | Capsule | 018651 | 02/01/2014 |
| Dronedarone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dronedarone_Hydrochloride_Tablets_022425_RV07-14.pdf | Draft | Oral | Tablet | 022425 | 07/22/2014 |
| Drospirenone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211367.pdf | Draft | Oral | Tablet | 211367 | 08/28/2020 |
| Drospirenone; Estetrol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214154.pdf | Draft | Oral | Tablet | 214154 | 11/17/2022 |
| Drospirenone; Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone_Estradiol_oral tablet_RLD 021355_RV01-16.pdf | Draft | Oral | Tablet | 021355 | 01/27/2016 |
| Drospirenone; Ethinyl Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone_EE_tabs_21676_RV11-13.pdf | Draft | Oral | Tablet | 021676 | 11/05/2013 |
| Drospirenone; Ethinyl Estradiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone;_Estradiol_tab(Yazmin)_21098_RC3-09.pdf | Draft | Oral | Tablet | 021098 | 03/01/2009 |
| Drospirenone; Ethinyl Estradiol; Levomefolate Calcium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone_EE_Levomefolate_tab_22532_22564_RC03-12.pdf | Draft | Oral | Tablet | 022532 022574 | 03/01/2012 |
| Droxidopa | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Droxidopa_Oral capsule_203202_RC06-15.pdf | Draft | Oral | Capsule | 203202 | 06/24/2015 |
| Duloxetine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021427.pdf | Draft | Oral | Capsule, Delayed Release Pellets | 021427 | 09/16/2019 |
| Duloxetine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212516.pdf | Draft | Oral | Capsule, Delayed Release | 212516 | 03/02/2020 |
| Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216974.pdf | Draft | Intravenous | Powder | 216974 | 02/15/2024 |
| Dutasteride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dutasteride_cap_21319_RC7-05.pdf | Final | Oral | Capsule | 021319 | 05/12/2008 |
| Dutasteride;Tamsulosin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dutasteride_tamsulosin_HCl_cap_22460_RV02-14.pdf | Draft | Oral | Capsule | 022460 | 02/01/2014 |
| Duvelisib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211155.pdf | Draft | Oral | Capsule | 211155 | 09/16/2019 |
Newly Added Guidances since February 15, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215413.pdf | Draft | Oral | Tablet, For Suspension | 215413 | 02/15/2024 |
| Adagrasib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216340.pdf | Draft | Oral | Tablet | 216340 | 02/15/2024 |
| Amoxicillin; Clarithromycin; Vonoprazan Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215152.pdf | Draft | Oral | Capsule, Tablet, Tablet | 215152 | 02/15/2024 |
| Amoxicillin; Vonoprazan Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215153.pdf | Draft | Oral | Capsule, Tablet | 215153 | 02/15/2024 |
| Baclofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215422.pdf | Draft | Oral | Granules | 215422 | 02/15/2024 |
| Budesonide; Formoterol Fumarate; Glycopyrrolate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212122.pdf | Draft | Inhalation | Aerosol, Metered | 212122 | 02/15/2024 |
| Caffeine; Ergotamine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_086557.pdf | Draft | Rectal | Suppository | 086557 009000 | 02/15/2024 |
| Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216974.pdf | Draft | Intravenous | Powder | 216974 | 02/15/2024 |
| Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213388.pdf | Draft | Oral | Capsule | 213388 | 02/15/2024 |
| Ferric Derisomaltose | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208171.pdf | Draft | Intravenous | Solution | 208171 | 02/15/2024 |
| Finasteride; Tadalafil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215423.pdf | Draft | Oral | Capsule | 215423 | 02/15/2024 |
| Flotufolastat F-18 Gallium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216023.pdf | Draft | Intravenous | Solution | 216023 | 02/15/2024 |
| Formoterol Fumarate; Glycopyrrolate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208294.pdf | Draft | Inhalation | Aerosol, Metered | 208294 | 02/15/2024 |
| Lenacapavir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215974.pdf | Draft | Oral | Tablet | 215974 | 02/15/2024 |
| Lenacapavir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215973.pdf | Draft | Subcutaneous | Solution | 215973 | 02/15/2024 |
| Mannitol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022368.pdf | Draft | Inhalation | Powder | 022368 | 02/15/2024 |
| Mannitol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202049.pdf | Draft | Inhalation | Powder | 202049 | 02/15/2024 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208969.pdf | Draft | Nasal | Spray, Metered | 208969 | 02/15/2024 |
| Niraparib Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214876.pdf | Draft | Oral | Tablet | 214876 | 02/15/2024 |
| Olutasidenib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215814.pdf | Draft | Oral | Capsule | 215814 | 02/15/2024 |
| Oxymetazoline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212520.pdf | Draft | Ophthalmic | Solution/Drops | 212520 | 04/02/2024 |
| Rivaroxaban | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215859.pdf | Draft | Oral | For Suspension | 215859 | 02/15/2024 |
| Sertraline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215133.pdf | Draft | Oral | Capsule | 215133 | 02/15/2024 |
| Sodium Phenylbutyrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214860.pdf | Draft | Oral | For Suspension | 214860 | 02/15/2024 |
| Sodium Phenylbutyrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216513.pdf | Draft | Oral | Pellets | 216513 | 02/15/2024 |
| Sodium Phenylbutyrate; Taurursodiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216660.pdf | Draft | Oral | For Suspension | 216660 | 02/15/2024 |
| Terlipressin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022231.pdf | Draft | Intravenous | Powder | 022231 | 02/15/2024 |
| Testosterone Undecanoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213953.pdf | Draft | Oral | Capsule | 213953 | 02/15/2024 |
| Xenon Xe-129 Hyperpolarized | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214375.pdf | Draft | Inhalation | Gas | 214375 | 02/15/2024 |
| Zanamivir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021036.pdf | Draft | Inhalation | Powder | 021036 | 02/15/2024 |
Newly Revised Guidances since February 15, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Aclidinium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202450.pdf | Draft | Inhalation | Powder, Metered | 202450 | 02/15/2024 |
| Aclidinium Bromide; Formoterol Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210595.pdf | Draft | Inhalation | Powder, Metered | 210595 | 02/15/2024 |
| Albuterol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf | Draft | Inhalation | Powder, Metered | 205636 | 02/15/2024 |
| Aprepitant | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf | Draft | Intravenous | Emulsion | 209296 216457 | 02/15/2024 |
| Betamethasone Dipropionate; Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020010.pdf | Draft | Topical | Lotion | 020010 076493 | 02/15/2024 |
| Betamethasone Dipropionate; Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018827.pdf | Draft | Topical | Cream | 018827 075673 | 02/15/2024 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf | Draft | Inhalation | Powder, Metered | 021949 | 02/15/2024 |
| Dapsone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207154.pdf | Draft | Topical | Gel | 207154 | 02/15/2024 |
| Dapsone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021794.pdf | Draft | Topical | Gel | 021794 | 02/15/2024 |
| Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050023.pdf | Draft | Ophthalmic | Suspension/Drops | 050023 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050616.pdf | Draft | Ophthalmic | Ointment | 050616 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050592.pdf | Draft | Ophthalmic | Suspension/Drops | 050592 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050818.pdf | Draft | Ophthalmic | Suspension/Drops | 050818 | 02/15/2024 |
| Diazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211635.pdf | Draft | Nasal | Spray | 211635 | 02/15/2024 |
| Doxepin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022036.pdf | Draft | Oral | Tablet | 022036 | 02/15/2024 |
| Ferric Carboxymaltose | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203565.pdf | Draft | Intravenous | Solution | 203565 | 02/15/2024 |
| Fluorometholone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016851.pdf | Draft | Ophthalmic | Suspension/Drops | 016851 | 02/15/2024 |
| Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf | Draft | Inhalation | Powder | 209482 | 02/15/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf | Draft | Inhalation | Powder | 208798 | 02/15/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf | Draft | Inhalation | Powder | 020833 | 02/15/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf | Draft | Inhalation | Powder | 021077 | 02/15/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf | Draft | Inhalation | Powder | 208799 | 02/15/2024 |
| Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060613.pdf | Draft | Otic | Suspension/Drops | 060613 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf | Draft | Ophthalmic | Suspension/Drops | 020583 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200738.pdf | Draft | Ophthalmic | Ointment | 200738 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020803.pdf | Draft | Ophthalmic | Suspension/Drops | 020803 | 02/15/2024 |
| Loteprednol Etabonate; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050804.pdf | Draft | Ophthalmic | Suspension/Drops | 050804 | 02/15/2024 |
| Mometasone Furoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf | Draft | Inhalation | Powder | 021067 | 02/15/2024 |
| Nilotinib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022068.pdf | Draft | Oral | Capsule | 022068 | 02/15/2024 |
| Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020692.pdf | Draft | Inhalation | Powder | 020692 | 02/15/2024 |
| Umeclidinium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205382.pdf | Draft | Inhalation | Powder | 205382 | 02/15/2024 |
| Umeclidinium Bromide; Vilanterol Trifenatate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203975.pdf | Draft | Inhalation | Powder | 203975 | 02/15/2024 |
| Vandetanib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022405.pdf | Draft | Oral | Tablet | 022405 | 02/15/2024 |