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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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.
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Total number of currently published PSGs: 2187
222 record(s) found for 'C'
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Cabotegravir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215499.pdf | Draft | Intramuscular | Suspension, Extended Release | 215499 | 05/18/2023 |
| Cabotegravir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212887.pdf | Draft | Oral | Tablet | 212887 | 08/02/2022 |
| Cabotegravir; Rilpivirine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212888.pdf | Draft | Intramuscular | Suspension, Extended Release | 212888 | 02/16/2023 |
| Cabozantinib S-Malate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203756.pdf | Draft | Oral | Capsule | 203756 | 05/18/2023 |
| Cabozantinib S-Malate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208692.pdf | Draft | Oral | Tablet | 208692 | 05/18/2023 |
| Caffeine; Ergotamine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_086557.pdf | Draft | Rectal | Suppository | 086557 009000 | 02/15/2024 |
| Calcifediol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208010.pdf | Draft | Oral | Capsule, Extended Release | 208010 | 03/24/2021 |
| Calcipotriene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022563.pdf | Draft | Topical | Aerosol, Foam | 022563 | 11/18/2020 |
| Calcipotriene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020554.pdf | Draft | Topical | Cream | 020554 | 10/21/2022 |
| Calcipotriene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020273.pdf | Draft | Topical | Ointment | 020273 | 10/21/2022 |
| Calcipotriene | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcipotriene_sol_20611_RC08-10.pdf | Draft | Topical | Solution | 020611 | 08/30/2010 |
| Calcitonin Salmon | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017769.pdf | Draft | Injection | Injectable | 017808 | 11/17/2022 |
| Calcitonin Salmon | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020313.pdf | Draft | Nasal | Spray, Metered | 020313 | 03/02/2020 |
| Calcitriol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcitriol_cap _18044_RC7-08.pdf | Draft | Oral | Capsule | 018044 | 09/01/2010 |
| Calcium Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcium acetate_oral tablet_ANDA 078502_RV03-17.pdf | Draft | Oral | Tablet | 019976 | 05/16/2017 |
| Calcium Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/calcium acetate_oral capsule_RLD 021160_RV03-17.pdf | Draft | Oral | Capsule | 021160 | 05/16/2017 |
| Calcium Carbonate; Famotidine; Magnesium Hydroxide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020958.pdf | Draft | Oral | Tablet, Chewable | 020958 | 11/17/2022 |
| Calcium Carbonate;Risedronate Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Risedronate_Sodium_Calcium_Carbonate_tab_21823_RC10-06.pdf | Final | Oral | Tablet, Tablet | 021823 | 05/12/2008 |
| Canagliflozin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Canagliflozin_tab_204042_RC07-14.pdf | Draft | Oral | Tablet | 204042 | 07/22/2014 |
| Canagliflozin; Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Canagliflozin; Metformin HCl_oral ER tablet_NDA 205879_RC08-17.pdf | Draft | Oral | Tablet, Extended Release | 205879 | 10/19/2017 |
| Canagliflozin; Metformin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Canagliflozin and Metformin HCl_oral tablet_204353_RC06-15.pdf | Draft | Oral | Tablet | 204353 | 06/24/2015 |
| Candesartan Cilexetil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Candesartan_Cilexetil_tab_20838_RC8-04.pdf | Final | Oral | Tablet | 020838 | 05/01/2008 |
| Candesartan Cilexetil; Hydrochlorothiazide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Candesartan_Cilexetil_HCTZ_tab_21093 _RC8-04.pdf | Draft | Oral | Tablet | 021093 | 09/01/2008 |
| Cannabidiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210365.pdf | Draft | Oral | Solution | 210365 | 03/24/2021 |
| Capecitabine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Capecitabine_Tabs_20896_RC09-12.pdf | Draft | Oral | Tablet | 020896 | 09/19/2012 |
| Capmatinib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213591.pdf | Draft | Oral | Tablet | 213591 | 02/17/2022 |
| Capsaicin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022395.pdf | Draft | Topical | Patch | 022395 | 11/21/2019 |
| Captopril | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Captopril_oral tablet_RLD 074434_RC09-16.pdf | Draft | Oral | Tablet | 018343 | 10/04/2016 |
| Carbamazepine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_oral tablet_016608_RV09-15.pdf | Draft | Oral | Tablet | 016608 | 09/18/2015 |
| Carbamazepine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_ER tab_020234_RV03-15.pdf | Draft | Oral | Tablet, Extended Release | 020234 | 03/06/2015 |
| Carbamazepine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_Oral ER cap_20712_RV03-15.pdf | Draft | Oral | Capsule, Extended Release | 020712 021710 | 03/06/2015 |
| Carbamazepine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_oral suspension_18927_RV03-15.pdf | Draft | Oral | Suspension | 018927 | 03/06/2015 |
| Carbamazepine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018281.pdf | Draft | Oral | Tablet, Chewable | 018281 | 08/02/2022 |
| Carbidopa | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa_Tabs_017830_RC07-14.pdf | Draft | Oral | Tablet | 017830 | 07/22/2014 |
| Carbidopa; Entacapone; Levodopa | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa_entacapone_levodopa_tab_21485_RV06-13.pdf | Draft | Oral | Tablet | 021485 | 06/19/2013 |
| Carbidopa; Levodopa | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa; Levedopa_enteral suspension_RLD 203952_RC03-17.pdf | Draft | Enteral | Suspension | 203952 | 05/16/2017 |
| Carbidopa; Levodopa | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa; Levodopa_oral tablet_RLD 17555_RC09-16.pdf | Draft | Oral | Tablet | 017555 | 10/04/2016 |
| Carbidopa; Levodopa | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa; Levodopa_oral ER capsule_203312_RC09-15.pdf | Draft | Oral | Capsule, Extended Release | 203312 | 09/18/2015 |
| Carbidopa; Levodopa | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa_Levodopa_ERtab_19856_RC09-12.pdf | Draft | Oral | Tablet, Extended Release | 019856 | 09/19/2012 |
| Carbidopa; Levodopa | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_076699.pdf | Draft | Oral | Tablet, Orally Disintegrating | 078690 | 11/08/2021 |
| Carbinoxamine Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008915.pdf | Draft | Oral | Tablet | 008915 | 08/20/2021 |
| Carbinoxamine Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbinoxamine_maleate_oralsusp_22556_RC07-14.pdf | Draft | Oral | Suspension, Extended Release | 022556 | 07/22/2014 |
| Carglumic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022562.pdf | Draft | Oral | Tablet | 022562 | 06/03/2020 |
| Cariprazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204370.pdf | Draft | Oral | Capsule | 204370 | 11/21/2019 |
| Carisoprodol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carisoprodol_tabs_11792_RC3-10.pdf | Draft | Oral | Tablet | 011792 | 03/19/2010 |
| Carvedilol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carvedilol_tab_20297_RC10-05.pdf | Final | Oral | Tablet | 020297 | 05/01/2008 |
| Carvedilol Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carvedilol_Phosphate_ERcap_22012_RC2-10.pdf | Draft | Oral | Capsule, Extended Release | 022012 | 02/25/2010 |
| Casimersen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213026.pdf | Draft | Intravenous | Solution | 213026 | 05/18/2023 |
| Caspofungin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021227.pdf | Draft | Intravenous | Powder | 021227 | 08/02/2022 |
| Cedazuridine; Decitabine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212576.pdf | Draft | Oral | Tablet | 212576 | 05/19/2022 |
| Cefaclor | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050673.pdf | Draft | Oral | Tablet, Extended Release | 050673 | 11/21/2019 |
| Cefaclor | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefaclor_cap_65350_RC2-11.pdf | Draft | Oral | Capsule | 050521 | 02/23/2011 |
| Cefadroxil; Cefadroxil Hemihydrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefadroxil;_Cefadroxil_Hemihydrate_65282_RC09-10.pdf | Draft | Oral | Capsule | 050512 | 09/30/2010 |
| Cefdinir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefdinir_cap_50739_RC1-08.pdf | Draft | Oral | Capsule | 050739 | 02/23/2008 |
| Cefdinir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefdinir_oral powder for suspension_ NDA 050749_RC05-17.pdf | Draft | Oral | Powder For Suspension | 050749 | 07/13/2017 |
| Cefditoren Pivoxil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefditoren_Pivoxil_tab_RLD 21222_RV3-10 minor edit after post.pdf | Final | Oral | Tablet | 021222 | 11/01/2015 |
| Cefiderocol Sulfate Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209445.pdf | Draft | Intravenous | Powder | 209445 | 08/20/2021 |
| Cefixime | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_chewtab_65380 RC07-14.pdf | Draft | Oral | Tablet, Chewable | 065380 | 07/22/2014 |
| Cefixime | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_cap_203195_RC04-13.pdf | Draft | Oral | Capsule | 203195 | 04/05/2013 |
| Cefixime | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_tab_65130_RC2-11.pdf | Draft | Oral | Tablet | 050621 | 02/23/2011 |
| Cefixime | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_susp_202091_RV11-13.pdf | Draft | Oral | Suspension | 202091 | 11/05/2013 |
| Cefpodoxime Proxetil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefpodoxime_Proxetil_Susp_65409_RC06-12.pdf | Draft | Oral | Suspension | 050675 | 06/14/2012 |
| Cefpodoxime Proxetil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefpodoxime_Proxetil_Tab_65462_RC06-12.pdf | Draft | Oral | Tablet | 050674 | 06/14/2012 |
| Cefprozil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefprozil_Susp_65261_RC06-12.pdf | Draft | Oral | Suspension | 050665 | 06/14/2012 |
| Cefprozil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefprozil_Tab_65276_RC06-12.pdf | Draft | Oral | Tablet | 050664 | 06/14/2012 |
| Cefuroxime Axetil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefuroxime_Axetil_tab_50605_RC08-10.pdf | Draft | Oral | Tablet | 050605 | 08/30/2010 |
| Cefuroxime Axetil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefuroxime_Axetil_susp_50672_RC02-10.pdf | Draft | Oral | Suspension | 050672 | 02/25/2010 |
| Celecoxib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Celecoxib_cap_20998_RV11-13.pdf | Draft | Oral | Capsule | 020998 | 11/05/2013 |
| Celecoxib; Tramadol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213426.pdf | Draft | Oral | Tablet | 213426 | 05/18/2023 |
| Cenobamate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212839.pdf | Draft | Oral | Tablet | 212839 | 11/08/2021 |
| Cephalexin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cephalexin_oral suspension_RLD 062703_RC12-16.pdf | Draft | Oral | Suspension | 050406 | 12/22/2016 |
| Cephalexin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cephalexin_cap_50405_RC12-08.pdf | Final | Oral | Capsule | 050405 | 10/28/2011 |
| Ceritinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ceritinib Oral Capsule NDA 205755 RV Feb 2019.pdf | Draft | Oral | Capsule | 205755 | 02/22/2019 |
| Ceritinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211225.pdf | Draft | Oral | Tablet | 211225 | 11/18/2020 |
| Cetirizine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022578.pdf | Draft | Oral | Tablet, Orally Disintegrating | 022578 | 11/08/2021 |
| Cetirizine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021621.pdf | Draft | Oral | Tablet, Chewable | 021621 | 08/02/2022 |
| Cetirizine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cetirizine hydrochloride_oral tablet_RLD 019835_RC12-16.pdf | Draft | Oral | Tablet | 019835 | 12/22/2016 |
| Cetirizine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cetirizine HCl_oral capsule_RLD 022429_Final 08-17.pdf | Final | Oral | Capsule | 022429 | 08/04/2017 |
| Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cetirizine_HCl;_Pseudoephedrine_HCl_ERtab_21150_RC2-08.pdf | Draft | Oral | Tablet, Extended Release | 021150 | 04/06/2008 |
| Cevimeline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cevimeline_HCl_cap_20989_RC9-05.pdf | Final | Oral | Capsule | 020989 | 05/01/2008 |
| Chenodiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018513.pdf | Draft | Oral | Tablet | 018513 | 09/16/2019 |
| Chlorambucil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorambucil_tabs_10669_RC07-10.pdf | Draft | Oral | Tablet | 010669 | 07/28/2010 |
| Chlordiazepoxide Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012249.pdf | Draft | Oral | Capsule | 012249 085475 085461 085472 | 09/16/2019 |
| Chlordiazepoxide Hydrochloride; Clidinium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlordiazepoxide clindinium_oral capsule_RLD 012750_RC03-17.pdf | Draft | Oral | Capsule | 012750 | 05/16/2017 |
| Chlorhexidine Gluconate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020774.pdf | Draft | Dental | Tablet | 020774 | 05/19/2022 |
| Chlorhexidine Gluconate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017768.pdf | Draft | Topical | Solution | 017768 | 11/16/2023 |
| Chloroprocaine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216227.pdf | Draft | Ophthalmic | Gel | 216227 | 08/21/2023 |
| Chloroquine Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_006002.pdf | Final | Oral | Tablet | 006002 | 04/13/2020 |
| Chlorothiazide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorothiazide Oral Suspension NDA 011870 PSG Page RC Feb 2019.pdf | Draft | Oral | Suspension | 011870 | 02/22/2019 |
| Chlorpheniramine Maleate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_007638.pdf | Draft | Oral | Tablet, Extended Release | 007638 | 09/16/2019 |
| Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/ChlorpheniramineMaleateIbuprofenPhenylephrine HCltablet022113RC03_15.pdf | Draft | Oral | Tablet | 022113 | 03/06/2015 |
| Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpheniramine maleate; Ibuprofen; Pseudoephendrine HCl Tablet 2mg; 200mg; 30mg NDA 021441 PSG Page RC May 2019.pdf | Draft | Oral | Tablet | 021441 | 05/15/2019 |
| Chlorpheniramine Polistirex; Codeine Polistirex | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpheniramine_polistirex_Codpoli_207768_RC04-16.pdf | Draft | Oral | Suspension, Extended Release | 207768 | 04/14/2016 |
| Chlorpheniramine Polistirex; Hydrocodone Polistirex | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpheniramine_Polistirex;_Hydrocodone_Polistirex_susp_19111_RC2-10.pdf | Draft | Oral | Suspension, Extended Release | 019111 | 02/25/2010 |
| Chlorpheniramine Polistirex; Hydrocodone Polistirex | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpheniramine_Polistirex;_ Hydrocodone_Plistirex_ERcap_77273_RC12-08.pdf | Draft | Oral | Capsule, Extended Release | 077273 | 12/20/2008 |
| Chlorpromazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorpromazine Hydrochloride Oral Tablet ANDA 84114 RV 09-2018.pdf | Draft | Oral | Tablet | 084112 084114 | 09/13/2018 |
| Chlorpromazine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009149.pdf | Draft | Oral | Concentrate | 009149 | 09/16/2019 |
| Chlorthalidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012283.pdf | Draft | Oral | Tablet 50 mg; 25 mg | 012283 | 09/16/2019 |
| Chlorthalidone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019574.pdf | Draft | Oral | Tablet 25 mg; 15 mg | 019574 | 09/16/2019 |
| Chlorzoxazone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011529-Tab-750MG.pdf | Draft | Oral | Tablet 750 mg | 011529 | 11/21/2019 |
| Chlorzoxazone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011300.pdf | Draft | Oral | Tablet | 011300 | 11/21/2019 |
| Chlorzoxazone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011529-Tab-500MG.pdf | Draft | Oral | Tablet 500 mg | 011529 | 11/21/2019 |
| Cholestyramine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cholestyramine_oral powder_74557 and 74558_RV06-15.pdf | Draft | Oral | Powder | 016640 019669 | 06/24/2015 |
| Cholic Acid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cholic acidz_oral capsule_RLD 205750_RC03-16.pdf | Draft | Oral | Capsule | 205750 | 10/04/2016 |
| Choline Fenofibrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Copy of Choline_Fenofibrate_DRtabs_22224_RC12-10.pdf | Draft | Oral | Capsule, Delayed Release | 022224 | 12/23/2010 |
| Ciclesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclesonide Nasal Aerosol 202129 RC09-12.pdf | Draft | Nasal | Aerosol, Metered | 202129 | 09/19/2012 |
| Ciclesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022004.pdf | Draft | Nasal | Spray, Metered | 022004 | 08/21/2023 |
| Ciclesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021658.pdf | Draft | Inhalation | Aerosol, Metered | 021658 | 08/21/2023 |
| Ciclopirox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Suspension NDA 019824 RV Feb 2019.pdf | Draft | Topical | Suspension | 019824 | 02/22/2019 |
| Ciclopirox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Cream NDA 018748 RV Feb 2019.pdf | Draft | Topical | Cream | 018748 | 02/22/2019 |
| Ciclopirox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Gel NDA 020519 RV Feb 2019.pdf | Draft | Topical | Gel | 020519 | 02/22/2019 |
| Ciclopirox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox_shmp_21159_RC2-10.pdf | Draft | Topical | Shampoo | 021159 | 02/25/2010 |
| Ciclopirox | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox_soln_21022_ RC2-10.pdf | Draft | Topical | Solution | 021022 | 02/23/2011 |
| Cilastatin Sodium; Imipenem; Relebactam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212819.pdf | Draft | Intravenous | Powder | 212819 | 07/15/2021 |
| Cilostazol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cilostazol_tab_20863_RC10-05.pdf | Final | Oral | Tablet | 020863 | 05/01/2008 |
| Cimetidine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017920.pdf | Draft | Oral | Tablet | 017920 | 11/16/2023 |
| Cinacalcet Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cinacalcet_HCl_tab_21688_RC11-05.pdf | Final | Oral | Tablet | 021688 | 05/01/2008 |
| Ciprofloxacin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_susp_20780_RC5-09.pdf | Final | Oral | Suspension | 020780 | 10/28/2011 |
| Ciprofloxacin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_draft_Otic susp injec_RLD 207986_RC07-18.pdf | Draft | Otic | Suspension, Injectable | 207986 | 07/20/2018 |
| Ciprofloxacin hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_draft_Ophthalmic ointment_RLD_020369_RC09-18.pdf | Draft | Ophthalmic | Ointment | 020369 | 09/13/2018 |
| Ciprofloxacin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin hydrochloride_ophthalmic solution_NDA 019992_RV08-17.pdf | Draft | Ophthalmic | Solution/Drops | 019992 | 10/19/2017 |
| Ciprofloxacin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_tabs_19537_RC09-10.pdf | Draft | Oral | Tablet | 019537 | 09/30/2010 |
| Ciprofloxacin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_ERtab_21744_RC11-07.pdf | Draft | Oral | Tablet, Extended Release | 021744 | 11/01/2007 |
| Ciprofloxacin Hydrochloride; Hydrocortisone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin HCL_Hydrocortisone_Otic susp_RLD 020805_RV01-16.pdf | Draft | Otic | Suspension/Drops | 020805 | 01/27/2016 |
| Ciprofloxacin; Ciprofloxacin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin; Ciprofloxacin Hydrochloride_ERtab_21473_RC1-08.pdf | Draft | Oral | Tablet, Extended Release | 021473 | 02/23/2008 |
| Ciprofloxacin; Dexamethasone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_Dexamethasone_Otic suspension_RLD 021537_RV04-16.pdf | Draft | Otic | Suspension/Drops | 021537 | 04/14/2016 |
| Citalopram Hydrobromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Citalopram hydrobromide_Oral Capsule_RLD 77668_Final 08-17.pdf | Final | Oral | Capsule | 077668 | 08/04/2017 |
| Citalopram Hydrobromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Citalopram hydrobromide_Oral Tablet_RLD 20822_Final 08-17.pdf | Final | Oral | Tablet | 020822 | 08/04/2017 |
| Citalopram Hydrobromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215428.pdf | Draft | Oral | Capsule | 215428 | 11/16/2023 |
| Citric Acid; Lactic Acid; Potassium Bitartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208352.pdf | Draft | Vaginal | Gel | 208352 | 05/18/2023 |
| Cladribine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022561.pdf | Draft | Oral | Tablet | 022561 | 02/17/2022 |
| Clarithromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clarithromycin_Oral Tablet_RLD 50662_Final 08-17.pdf | Final | Oral | Tablet | 050662 | 08/04/2017 |
| Clarithromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clarithromycin_ERtab_50775_RC1-08.pdf | Draft | Oral | Tablet, Extended Release | 050775 | 02/23/2008 |
| Clarithromycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clarithromycin_susp_50698_RC5-05.pdf | Final | Oral | Suspension | 050698 | 05/01/2008 |
| Clascoterone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213433.pdf | Draft | Topical | Cream | 213433 | 08/21/2023 |
| Clemastine Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017661.pdf | Draft | Oral | Tablet 2.68 mg | 017661 | 09/16/2019 |
| Clemastine Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020925.pdf | Draft | Oral | Tablet 1.34 mg | 020925 | 09/16/2019 |
| Clevidipine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022156.pdf | Draft | Intravenous | Emulsion | 022156 | 03/02/2020 |
| Clindamycin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin HCl_Oral Capsule_RLD 50162_Final 08-17.pdf | Final | Oral | Capsule | 050162 | 08/04/2017 |
| Clindamycin Phosphae | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050782.pdf | Draft | Topical | Gel | 050782 | 10/21/2022 |
| Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215650.pdf | Draft | Vaginal | Gel | 215650 | 11/17/2022 |
| Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050537-Sol.pdf | Draft | Topical | Solution | 050537 | 06/03/2020 |
| Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050537-Swa.pdf | Draft | Topical | Swab | 050537 | 06/03/2020 |
| Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050801.pdf | Draft | Topical | Aerosol, Foam | 050801 | 06/03/2020 |
| Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin_Phosphate_crm_50680_RC03-12.pdf | Draft | Vaginal | Cream | 050680 | 03/28/2012 |
| Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin_Phosphate_crm_50793_RC03-12.pdf | Draft | Vaginal | Cream | 050793 | 03/28/2012 |
| Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin_Phosphate_supp_50767_RC03-12.pdf | Draft | Vaginal | Suppository | 050767 | 03/28/2012 |
| Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050615.pdf | Draft | Topical | Gel | 050615 | 10/21/2022 |
| Clindamycin Phosphate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050600.pdf | Draft | Topical | Lotion | 050600 | 11/21/2023 |
| Clindamycin Phosphate; Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050802.pdf | Draft | Topical | Gel | 050802 | 10/21/2022 |
| Clindamycin Phosphate; Tretinoin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050803.pdf | Draft | Topical | Gel | 050803 | 10/21/2022 |
| Clobazam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210833.pdf | Draft | Oral | Film | 210833 | 11/18/2020 |
| Clobazam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobazam_susp_203993_RC02-14.pdf | Draft | Oral | Suspension | 203993 | 04/01/2014 |
| Clobazam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobazam_tab_202067_RV11-13.pdf | Draft | Oral | Tablet | 202067 | 11/05/2013 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol Propionate_Emollient Cream 0.05_RLD 75430_RC09-16.pdf | Draft | Topical | Cream | 020340 | 10/04/2016 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol Propionate_topical gel 0.05_RLD 75368_RC09-16.pdf | Draft | Topical | Gel | 020337 | 10/04/2016 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol propionate_topical lotion_RLD 21535_RC04-16.pdf | Draft | Topical | Lotion | 021535 | 04/14/2016 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_fmaerosol_21142_RC2-11.pdf | Draft | Topical | Aerosol, Foam | 021142 | 02/23/2011 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_shmp_21644_RC2-11.pdf | Draft | Topical | Shampoo | 021644 | 02/23/2011 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_spray_21835_RC2-11.pdf | Draft | Topical | Spray | 021835 | 02/23/2011 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_sol_19966_RC08-10.pdf | Draft | Topical | Solution | 019966 | 08/30/2010 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol propionate_topical ointment_RLD 019323_RC01-16.pdf | Draft | Topical | Ointment | 019323 | 01/27/2016 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022013.pdf | Draft | Topical | Aerosol, Foam | 022013 | 11/18/2020 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213691.pdf | Draft | Topical | Lotion | 213691 | 05/18/2023 |
| Clobetasol Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol propionate_topical cream_RLD 74220_RC04-16.pdf | Draft | Topical | Cream | 019322 | 04/14/2016 |
| Clocortolone Pivalate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clocortolone pivalate_topical cream_ NDA 017765_RC05-17.pdf | Draft | Topical | Cream | 017765 | 07/13/2017 |
| Clomiphene Citrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clomiphene citrate_Oral tablet_RLD 16131_Final 08-17.pdf | Final | Oral | Tablet | 016131 | 08/04/2017 |
| Clomipramine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clomipramine hydrochloride_oral capsule_019906_RC09-15.pdf | Draft | Oral | Capsule | 019906 | 09/18/2015 |
| Clonazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonazepam_orally disintegrating tablet_ANDA 077171_RC03-17.pdf | Draft | Oral | Tablet, Orally Disintegrating | 020813 | 05/16/2017 |
| Clonazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonazepam_Oral Tablet_RLD 17533_Final 08-17.pdf | Final | Oral | Tablet | 017533 | 08/04/2017 |
| Clonidine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonidine_ERtab_22500_RC08-10.pdf | Draft | Oral | Tablet, Extended Release | 022500 | 08/30/2010 |
| Clonidine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018891.pdf | Draft | Transdermal | Film, Extended Release | 018891 | 11/21/2019 |
| Clonidine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonidine hydrochloride_oral tablet_022331_RC09-15.pdf | Draft | Oral | Tablet, Extended Release | 022331 | 09/18/2015 |
| Clonidine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017407.pdf | Draft | Oral | Tablet | 017407 | 11/21/2019 |
| Clopidogrel Bisulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clopidogrel_Bisulfate_tab_20839_RC10-05.pdf | Draft | Oral | Tablet | 020839 | 08/01/2008 |
| Clorazepate Dipotassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clorazepate_Dipotassium_tab_17105_RC12-12.pdf | Draft | Oral | Tablet | 017105 | 12/14/2012 |
| Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Topical Solution NDA 018181 RV Feb 2019.pdf | Draft | Topical | Solution | 018181 | 02/22/2019 |
| Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Topical Cream ANDA 072640 RV Feb 2019.pdf | Draft | Topical | Cream | 072640 | 02/22/2019 |
| Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Cream NDA 018052 RV Feb 2019.pdf | Draft | Vaginal | Cream | 018052 | 02/22/2019 |
| Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Cream NDA 020574 RV Feb 2019.pdf | Draft | Vaginal | Cream | 020574 | 02/22/2019 |
| Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Tablet NDA 017717 RV Feb 2019.pdf | Draft | Vaginal | Tablet | 017717 | 02/22/2019 |
| Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Tablet NDA 020525 RV Feb 2019.pdf | Draft | Vaginal | Tablet | 020525 | 02/22/2019 |
| Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole_loz_18713_RC9-08.pdf | Draft | Oral | Troche/Lozenge | 018713 | 09/01/2008 |
| Clozapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203479.pdf | Draft | Oral | Suspension | 203479 | 02/17/2022 |
| Clozapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019758.pdf | Draft | Oral | Tablet | 019758 | 02/17/2022 |
| Clozapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021590.pdf | Draft | Oral | Tablet, Orally Disintegrating | 021590 | 02/17/2022 |
| Cobicistat | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat_oral tablet_203094_RC09-15.pdf | Draft | Oral | Tablet | 203094 | 09/18/2015 |
| Cobicistat; Darunavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat; Darunavir ethanolate_oral tablet_RLD 205395_RV12-16.pdf | Draft | Oral | Tablet | 205395 | 12/22/2016 |
| Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210455.pdf | Draft | Oral | Tablet | 210455 | 08/02/2022 |
| Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat; ElviteNDA 207561_RV08-17.pdf | Draft | Oral | Tablet | 207561 | 10/19/2017 |
| Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat_Elvitegravir..._203100_RC12-14.pdf | Draft | Oral | Tablet | 203100 | 12/29/2014 |
| Cobimetinib Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobimetinib Fumarate _oral tablet_RLD 206192_RC06-16.pdf | Draft | Oral | Tablet | 206192 | 06/16/2016 |
| Cocaine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209575.pdf | Draft | Nasal | Solution | 209575 | 05/19/2022 |
| Cocaine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209963.pdf | Draft | Nasal | Solution | 209963 | 12/13/2019 |
| Colchicine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Colchicine_oral capsule_RLD 204820_RC12-16.pdf | Draft | Oral | Capsule | 204820 | 12/22/2016 |
| Colchicine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Colchicine_tab_22352_RC09-10.pdf | Draft | Oral | Tablet | 022352 | 09/30/2010 |
| Colesevelam Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210895.pdf | Draft | Oral | Bar, Chewable | 210895 | 11/08/2021 |
| Colesevelam Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021176.pdf | Draft | Oral | Tablet | 021176 | 11/08/2021 |
| Colesevelam Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022362.pdf | Draft | Oral | For Suspension | 022362 | 11/08/2021 |
| Colestipol Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Colestipol_Hydrochloride_tab_20222_RC07-14.pdf | Draft | Oral | Tablet | 020222 | 07/22/2014 |
| Copper | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018680.pdf | Draft | Intrauterine | Intrauterine Device | 018680 | 11/21/2019 |
| Copper Dotatate Cu-64 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213227.pdf | Draft | Intravenous | Solution | 213227 | 08/20/2021 |
| Crisaborole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207695.pdf | Draft | Topical | Ointment | 207695 | 10/21/2022 |
| Crizotinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Crizotinib_Caps_202570_RC07-14.pdf | Draft | Oral | Capsule | 202570 | 07/22/2014 |
| Crofelemer | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202292.pdf | Draft | Oral | Tablet, Delayed Release | 202292 | 11/18/2020 |
| Crotamiton | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_006927.pdf | Draft | Topical | Cream | 006927 | 10/21/2022 |
| Crotamiton | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009112.pdf | Draft | Topical | Lotion | 009112 | 10/21/2022 |
| Cyanocobalamin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyanocobalamin_nasal metered spray_NDA 021642_RC05-17.pdf | Draft | Nasal | Spray | 021642 | 07/13/2017 |
| Cyclobenzaprine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclobenzaprine HCl_oral tablet _RLD 17821_final 08-17.pdf | Final | Oral | Tablet | 017821 | 08/04/2017 |
| Cyclobenzaprine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclobenzaprine HCL_oral ER capsule_RLD 21777_RV12-16.pdf | Draft | Oral | Capsule, Extended Release | 021777 | 11/23/2016 |
| Cyclophosphamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclophosphamide_oral tablet_040032_RV09-15.pdf | Draft | Oral | Tablet | 040032 | 09/18/2015 |
| Cyclophosphamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclophosphamide_oral capsule_203856_RC06-15.pdf | Draft | Oral | Capsule | 203856 | 06/24/2015 |
| Cycloserine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cycloserine_oral capsule_RLD 060593_Final 08-17.pdf | Final | Oral | Capsule | 060593 | 08/04/2017 |
| Cyclosporine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214965.pdf | Draft | Ophthalmic | Emulsion | 214965 | 08/02/2022 |
| Cyclosporine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine ophthalmic solution 0.09 NDA 210913 PSG Page RC May 2019.pdf | Draft | Ophthalmic | Solution/Drops | 210913 | 05/15/2019 |
| Cyclosporine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine_Oral capsule_RLD 050625_RV04-16.pdf | Draft | Oral | Capsule | 050625 | 04/14/2016 |
| Cyclosporine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine_Oral capsule_RLD 050715_RV04-16.pdf | Draft | Oral | Capsule | 050715 | 04/14/2016 |
| Cyclosporine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine_ophthalmic emulsion_RLD 050790_RV09-16.pdf | Draft | Ophthalmic | Emulsion | 050790 | 10/04/2016 |
| Cyproheptadine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyproheptadine hydrochloride_Oral tablet_087056_RC06-15.pdf | Draft | Oral | Tablet | 012649 | 06/24/2015 |
| Cysteamine Bitartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cysteamine bitartrate_oral DR capsule_NDA 203389_RV11-17.pdf | Draft | Oral | Capsule, Delayed Release | 203389 | 02/08/2018 |
| Cysteamine Bitartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213491.pdf | Draft | Oral | Granule, Delayed Release | 213491 | 03/24/2021 |
| Cytarabine; Daunorubicin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209401.pdf | Draft | Intravenous | Powder | 209401 | 08/02/2022 |
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 |