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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 reference listed drug.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate bioequivalence depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach available among those set forth in 21 CFR 320.24. As the initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).

To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances describing the Agency's current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs.

FDA publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs

These guidances are published in an incremental manner and listed below in alphabetical order according to the active ingredient's name. The most recently published guidances (new and revised) are listed below.

Additionally, as part of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference listed drugs that are (1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to the earliest lawful ANDA filing date. 1 This goal does not include complex products as defined in the GDUFA II Commitment Letter. FDA will strive to issue guidance for a complex product as soon as scientific recommendations are available.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or bioequivalence (BE) and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct; including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring.

Some of the product-specific guidances include discussion regarding data formats. Please note that under section 745A(a) of the Federal Food, Drug, and Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified must be used for submissions to ANDAs. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at esub@fda.hhs.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

COMMENTS: The Agency is seeking feedback and considers comments to the docket on these guidances. You may submit comments on any guidance at any time as follows: Submit electronic comments to Docket FDA-2007-D-0369. For further information on submitting electronic comments, refer to the regulations.gov website (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 product-specific guidances on the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page

For additional information on development of generic drug products, please refer to FDA's guidance document database.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter)

Total number of currently published PSGs: 2032

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


209 record(s) found for 'C'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Cabotegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212887.pdf Draft Oral Tablet 212887 08/2022
Cabozantinib S Malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cabozantinib S-malate_oral capsules_NDA 203756_RC11-17.pdf Draft Oral Capsule 203756 02/2018
Cabozantinib S malate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cabozantinib S-Malate_oral tablet_NDA 208692_RC11-17.pdf Draft Oral Tablet 208692 02/2018
Calcifediol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208010.pdf Draft Oral Capsule, Extended Release 208010 03/2021
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022563.pdf Draft Topical Aerosol, Foam 022563 11/2020
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcipotriene Topical Emulsion Cream NDA 020554 RV Feb 2019.pdf Draft Topical Cream 020554 02/2019
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcipotriene Topical Ointment NDA 020273 RV Feb 2019.pdf Draft Topical Ointment 020273 02/2019
Calcipotriene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcipotriene_sol_20611_RC08-10.pdf Draft Topical Solution 020611 08/2010
Calcitonin Salmon https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020313.pdf Draft Nasal Spray, Metered 020313 03/2020
Calcitriol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcitriol_cap _18044_RC7-08.pdf Draft Oral Capsule 018044 09/2010
Calcium Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/calcium acetate_oral capsule_RLD 021160_RV03-17.pdf Draft Oral Capsule 021160 05/2017
Calcium Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcium acetate_oral tablet_ANDA 078502_RV03-17.pdf Draft Oral Tablet 019976 05/2017
Calcium Carbonate; Famotidine; Magnesium Hydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Calcium carbonate_Famotidine_Magnesium hydroxide_Oral tablet_020958_RC06-15.pdf Draft Oral Tablet, Chewable 020958 06/2015
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 05/2008
Canagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Canagliflozin_tab_204042_RC07-14.pdf Draft Oral Tablet 204042 07/2014
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 06/2015
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 10/2017
Candesartan Cilexetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Candesartan_Cilexetil_tab_20838_RC8-04.pdf Final Oral Tablet 020838 05/2008
Candesartan Cilexetil; Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Candesartan_Cilexetil_HCTZ_tab_21093 _RC8-04.pdf Draft Oral Tablet 021093 09/2008
Cannabidiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210365.pdf Draft Oral Solution 210365 03/2021
Capecitabine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Capecitabine_Tabs_20896_RC09-12.pdf Draft Oral Tablet 020896 09/2012
Capmatinib Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213591.pdf Draft Oral Tablet 213591 02/2022
Capsaicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022395.pdf Draft Topical Patch 022395 11/2019
Captopril https://www.accessdata.fda.gov/drugsatfda_docs/psg/Captopril_oral tablet_RLD 074434_RC09-16.pdf Draft Oral Tablet 018343 10/2016
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_oral tablet_016608_RV09-15.pdf Draft Oral Tablet 016608 09/2015
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_oral suspension_18927_RV03-15.pdf Draft Oral Suspension 018927 03/2015
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_Oral ER cap_20712_RV03-15.pdf Draft Oral Capsule, Extended Release 020712 021710 03/2015
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbamazepine_ER tab_020234_RV03-15.pdf Draft Oral Tablet, Extended Release 020234 03/2015
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018281.pdf Draft Oral Tablet, Chewable 018281 08/2022
Carbidopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa_Tabs_017830_RC07-14.pdf Draft Oral Tablet 017830 07/2014
Carbidopa; Entacapone; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa_entacapone_levodopa_tab_21485_RV06-13.pdf Draft Oral Tablet 021485 06/2013
Carbidopa; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa; Levodopa_oral tablet_RLD 17555_RC09-16.pdf Draft Oral Tablet 017555 10/2016
Carbidopa; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa; Levedopa_enteral suspension_RLD 203952_RC03-17.pdf Draft Enteral Suspension 203952 05/2017
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 09/2015
Carbidopa; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_076699.pdf Draft Oral Tablet, Orally Disintegrating 078690 11/2021
Carbidopa; Levodopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbidopa_Levodopa_ERtab_19856_RC09-12.pdf Draft Oral Tablet, Extended Release 019856 09/2012
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carbinoxamine_maleate_oralsusp_22556_RC07-14.pdf Draft Oral Suspension, Extended Release 022556 07/2014
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008915.pdf Draft Oral Tablet 008915 08/2021
Carglumic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022562.pdf Draft Oral Tablet 022562 06/2020
Cariprazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204370.pdf Draft Oral Capsule 204370 11/2019
Carisoprodol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carisoprodol_tabs_11792_RC3-10.pdf Draft Oral Tablet 011792 03/2010
Carvedilol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carvedilol_tab_20297_RC10-05.pdf Final Oral Tablet 020297 05/2008
Carvedilol Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Carvedilol_Phosphate_ERcap_22012_RC2-10.pdf Draft Oral Capsule, Extended Release 022012 02/2010
Caspofungin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021227.pdf Draft Intravenous Powder 021227 08/2022
Cedazuridine; Decitabine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212576.pdf Draft Oral Tablet 212576 05/2022
Cefaclor https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050673.pdf Draft Oral Tablet, Extended Release 050673 11/2019
Cefaclor https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefaclor_cap_65350_RC2-11.pdf Draft Oral Capsule 050521 02/2011
Cefadroxil; Cefadroxil Hemihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefadroxil;_Cefadroxil_Hemihydrate_65282_RC09-10.pdf Draft Oral Capsule 050512 09/2010
Cefdinir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefdinir_cap_50739_RC1-08.pdf Draft Oral Capsule 050739 01/2008
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 07/2017
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 11/2015
Cefiderocol Sulfate Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209445.pdf Draft Intravenous Powder 209445 08/2021
Cefixime https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_cap_203195_RC04-13.pdf Draft Oral Capsule 203195 04/2013
Cefixime https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_tab_65130_RC2-11.pdf Draft Oral Tablet 050621 02/2011
Cefixime https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_susp_202091_RV11-13.pdf Draft Oral Suspension 202091 11/2013
Cefixime https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefixime_chewtab_65380 RC07-14.pdf Draft Oral Tablet, Chewable 065380 07/2014
Cefpodoxime Proxetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefpodoxime_Proxetil_Tab_65462_RC06-12.pdf Draft Oral Tablet 050674 06/2012
Cefpodoxime Proxetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefpodoxime_Proxetil_Susp_65409_RC06-12.pdf Draft Oral Suspension 050675 06/2012
Cefprozil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefprozil_Susp_65261_RC06-12.pdf Draft Oral Suspension 050665 06/2012
Cefprozil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefprozil_Tab_65276_RC06-12.pdf Draft Oral Tablet 050664 06/2012
Cefuroxime Axetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefuroxime_Axetil_tab_50605_RC08-10.pdf Draft Oral Tablet 050605 08/2010
Cefuroxime Axetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cefuroxime_Axetil_susp_50672_RC02-10.pdf Draft Oral Suspension 050672 02/2010
Celecoxib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Celecoxib_cap_20998_RV11-13.pdf Draft Oral Capsule 020998 11/2013
Cenobamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212839.pdf Draft Oral Tablet 212839 11/2021
Cephalexin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cephalexin_cap_50405_RC12-08.pdf Final Oral Capsule 050405 10/2011
Cephalexin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cephalexin_oral suspension_RLD 062703_RC12-16.pdf Draft Oral Suspension 050406 12/2016
Ceritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211225.pdf Draft Oral Tablet 211225 11/2020
Ceritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ceritinib Oral Capsule NDA 205755 RV Feb 2019.pdf Draft Oral Capsule 205755 02/2019
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cetirizine HCl_oral capsule_RLD 022429_Final 08-17.pdf Final Oral Capsule 022429 08/2017
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cetirizine hydrochloride_oral tablet_RLD 019835_RC12-16.pdf Draft Oral Tablet 019835 12/2016
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021621.pdf Draft Oral Tablet, Chewable 021621 08/2022
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022578.pdf Draft Oral Tablet, Orally Disintegrating 022578 11/2021
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 02/2008
Cevimeline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cevimeline_HCl_cap_20989_RC9-05.pdf Final Oral Capsule 020989 05/2008
Chenodiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018513.pdf Draft Oral Tablet 018513 09/2019
Chlorambucil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorambucil_tabs_10669_RC07-10.pdf Draft Oral Tablet 010669 07/2010
Chlordiazepoxide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012249.pdf Draft Oral Capsule 012249 09/2019
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 05/2017
Chlorhexidine Gluconate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020774.pdf Draft Dental Tablet 020774 05/2022
Chloroquine Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_006002.pdf Final Oral Tablet 006002 04/2020
Chlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Chlorothiazide Oral Suspension NDA 011870 PSG Page RC Feb 2019.pdf Draft Oral Suspension 011870 02/2019
Chlorpheniramine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_007638.pdf Draft Oral Tablet, Extended Release 007638 09/2019
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/ChlorpheniramineMaleateIbuprofenPhenylephrine HCltablet022113RC03_15.pdf Draft Oral Tablet 022113 03/2015
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 05/2019
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 04/2016
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 02/2010
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 12/2008
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 09/2018
Chlorpromazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009149.pdf Draft Oral Concentrate 009149 09/2019
Chlorthalidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012283.pdf Draft Oral Tablet 50 mg; 25 mg 012283 09/2019
Chlorthalidone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019574.pdf Draft Oral Tablet 25 mg; 15 mg 019574 09/2019
Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011300.pdf Draft Oral Tablet 011300 11/2019
Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011529-Tab-500MG.pdf Draft Oral Tablet 500 mg 011529 11/2019
Chlorzoxazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011529-Tab-750MG.pdf Draft Oral Tablet 750 mg 011529 11/2019
Cholestyramine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cholestyramine_oral powder_74557 and 74558_RV06-15.pdf Draft Oral Powder 016640 019669 06/2015
Cholic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cholic acidz_oral capsule_RLD 205750_RC03-16.pdf Draft Oral Capsule 205750 10/2016
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 12/2010
Ciclesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021658.pdf Draft Inhalation Aerosol, Metered 021658 03/2021
Ciclesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclesonide Nasal Aerosol 202129 RC09-12.pdf Draft Nasal Aerosol, Metered 202129 09/2012
Ciclesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022004.pdf Draft Nasal Spray, Metered 022004 11/2021
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Suspension NDA 019824 RV Feb 2019.pdf Draft Topical Suspension 019824 02/2019
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox_shmp_21159_RC2-10.pdf Draft Topical Shampoo 021159 02/2010
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox_soln_21022_ RC2-10.pdf Draft Topical Solution 021022 02/2011
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Gel NDA 020519 RV Feb 2019.pdf Draft Topical Gel 020519 02/2019
Ciclopirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciclopirox Topical Cream NDA 018748 RV Feb 2019.pdf Draft Topical Cream 018748 02/2019
Cilastatin Sodium; Imipenem; Relebactam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212819.pdf Draft Intravenous Powder 212819 07/2021
Cilostazol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cilostazol_tab_20863_RC10-05.pdf Final Oral Tablet 020863 05/2008
Cinacalcet Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cinacalcet_HCl_tab_21688_RC11-05.pdf Final Oral Tablet 021688 05/2008
Ciprofloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_draft_Otic susp injec_RLD 207986_RC07-18.pdf Draft Otic Suspension, Injectable 207986 07/2018
Ciprofloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_susp_20780_RC5-09.pdf Final Oral Suspension 020780 10/2011
Ciprofloxacin hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_draft_Ophthalmic ointment_RLD_020369_RC09-18.pdf Draft Ophthalmic Ointment 020369 09/2018
Ciprofloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_tabs_19537_RC09-10.pdf Draft Oral Tablet 019537 09/2010
Ciprofloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin hydrochloride_ophthalmic solution_NDA 019992_RV08-17.pdf Draft Ophthalmic Solution/Drops 019992 10/2017
Ciprofloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_HCl_ERtab_21744_RC11-07.pdf Draft Oral Tablet, Extended Release 021744 11/2007
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 01/2016
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 01/2008
Ciprofloxacin; Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Ciprofloxacin_Dexamethasone_Otic suspension_RLD 021537_RV04-16.pdf Draft Otic Suspension/Drops 021537 04/2016
Citalopram Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Citalopram hydrobromide_Oral Tablet_RLD 20822_Final 08-17.pdf Final Oral Tablet 020822 08/2017
Citalopram Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Citalopram hydrobromide_Oral Capsule_RLD 77668_Final 08-17.pdf Final Oral Capsule 077668 08/2017
Cladribine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022561.pdf Draft Oral Tablet 022561 02/2022
Clarithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clarithromycin_susp_50698_RC5-05.pdf Final Oral Suspension 050698 05/2008
Clarithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clarithromycin_Oral Tablet_RLD 50662_Final 08-17.pdf Final Oral Tablet 050662 08/2017
Clarithromycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clarithromycin_ERtab_50775_RC1-08.pdf Draft Oral Tablet, Extended Release 050775 01/2008
Clascoterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213433.pdf Draft Topical Cream 213433 11/2021
Clemastine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017661.pdf Draft Oral Tablet 2.68 mg 017661 09/2019
Clemastine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020925.pdf Draft Oral Tablet 1.34 mg 020925 09/2019
Clevidipine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022156.pdf Draft Intravenous Emulsion 022156 03/2020
Clindamycin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin HCl_Oral Capsule_RLD 50162_Final 08-17.pdf Final Oral Capsule 050162 08/2017
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050801.pdf Draft Topical Aerosol, Foam 050801 06/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin_Phosphate_crm_50680_RC03-12.pdf Draft Vaginal Cream 050680 03/2012
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin_Phosphate_crm_50793_RC03-12.pdf Draft Vaginal Cream 050793 03/2012
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050782.pdf Draft Topical Gel 050782 06/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050615.pdf Draft Topical Gel 050615 11/2019
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050600.pdf Draft Topical Lotion 050600 11/2019
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050537-Swa.pdf Draft Topical Swab 050537 06/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050537-Sol.pdf Draft Topical Solution 050537 06/2020
Clindamycin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clindamycin_Phosphate_supp_50767_RC03-12.pdf Draft Vaginal Suppository 050767 03/2012
Clindamycin Phosphate; Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050802.pdf Draft Topical Gel 050802 06/2020
Clindamycin Phosphate; Tretinoin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050803.pdf Draft Topical Gel 050803 06/2020
Clobazam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210833.pdf Draft Oral Film 210833 11/2020
Clobazam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobazam_susp_203993_RC02-14.pdf Draft Oral Suspension 203993 04/2014
Clobazam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobazam_tab_202067_RV11-13.pdf Draft Oral Tablet 202067 11/2013
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_spray_21835_RC2-11.pdf Draft Topical Spray 021835 02/2011
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_sol_19966_RC08-10.pdf Draft Topical Solution 019966 08/2010
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_shmp_21644_RC2-11.pdf Draft Topical Shampoo 021644 02/2011
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 10/2016
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol propionate_topical cream_RLD 74220_RC04-16.pdf Draft Topical Cream 019322 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 10/2016
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol propionate_topical lotion_RLD 21535_RC04-16.pdf Draft Topical Lotion 021535 04/2016
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol propionate_topical ointment_RLD 019323_RC01-16.pdf Draft Topical Ointment 019323 01/2016
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clobetasol_Propionate_fmaerosol_21142_RC2-11.pdf Draft Topical Aerosol, Foam 021142 02/2011
Clobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022013.pdf Draft Topical Aerosol, Foam 022013 11/2020
Clocortolone Pivalate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clocortolone pivalate_topical cream_ NDA 017765_RC05-17.pdf Draft Topical Cream 017765 07/2017
Clomiphene Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clomiphene citrate_Oral tablet_RLD 16131_Final 08-17.pdf Final Oral Tablet 016131 08/2017
Clomipramine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clomipramine hydrochloride_oral capsule_019906_RC09-15.pdf Draft Oral Capsule 019906 09/2015
Clonazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonazepam_Oral Tablet_RLD 17533_Final 08-17.pdf Final Oral Tablet 017533 08/2017
Clonazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonazepam_orally disintegrating tablet_ANDA 077171_RC03-17.pdf Draft Oral Tablet, Orally Disintegrating 020813 05/2017
Clonidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonidine_ERtab_22500_RC08-10.pdf Draft Oral Tablet, Extended Release 022500 08/2010
Clonidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018891.pdf Draft Transdermal Film, Extended Release 018891 11/2019
Clonidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clonidine hydrochloride_oral tablet_022331_RC09-15.pdf Draft Oral Tablet, Extended Release 022331 09/2015
Clonidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017407.pdf Draft Oral Tablet 017407 11/2019
Clopidogrel Bisulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clopidogrel_Bisulfate_tab_20839_RC10-05.pdf Draft Oral Tablet 020839 08/2008
Clorazepate Dipotassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clorazepate_Dipotassium_tab_17105_RC12-12.pdf Draft Oral Tablet 017105 12/2012
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole_loz_18713_RC9-08.pdf Draft Oral Troche/Lozenge 018713 09/2008
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Cream NDA 018052 RV Feb 2019.pdf Draft Vaginal Cream 018052 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Cream NDA 020574 RV Feb 2019.pdf Draft Vaginal Cream 020574 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Topical Cream ANDA 072640 RV Feb 2019.pdf Draft Topical Cream 072640 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Topical Solution NDA 018181 RV Feb 2019.pdf Draft Topical Solution 018181 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Tablet NDA 017717 RV Feb 2019.pdf Draft Vaginal Tablet 017717 02/2019
Clotrimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Clotrimazole Vaginal Tablet NDA 020525 RV Feb 2019.pdf Draft Vaginal Tablet 020525 02/2019
Clozapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203479.pdf Draft Oral Suspension 203479 02/2022
Clozapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021590.pdf Draft Oral Tablet, Orally Disintegrating 021590 02/2022
Clozapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019758.pdf Draft Oral Tablet 019758 02/2022
Cobicistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat_oral tablet_203094_RC09-15.pdf Draft Oral Tablet 203094 09/2015
Cobicistat; Darunavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat; Darunavir ethanolate_oral tablet_RLD 205395_RV12-16.pdf Draft Oral Tablet 205395 12/2016
Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210455.pdf Draft Oral Tablet 210455 08/2022
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat; ElviteNDA 207561_RV08-17.pdf Draft Oral Tablet 207561 10/2017
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobicistat_Elvitegravir..._203100_RC12-14.pdf Draft Oral Tablet 203100 12/2014
Cobimetinib Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cobimetinib Fumarate _oral tablet_RLD 206192_RC06-16.pdf Draft Oral Tablet 206192 06/2016
Cocaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209575.pdf Draft Nasal Solution 209575 05/2022
Cocaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209963.pdf Draft Nasal Solution 209963 12/2019
Colchicine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Colchicine_oral capsule_RLD 204820_RC12-16.pdf Draft Oral Capsule 204820 12/2016
Colchicine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Colchicine_tab_22352_RC09-10.pdf Draft Oral Tablet 022352 09/2010
Colesevelam Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210895.pdf Draft Oral Bar, Chewable 210895 11/2021
Colesevelam Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022362.pdf Draft Oral For Suspension 022362 11/2021
Colesevelam Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021176.pdf Draft Oral Tablet 021176 11/2021
Colestipol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Colestipol_Hydrochloride_tab_20222_RC07-14.pdf Draft Oral Tablet 020222 07/2014
Copper https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018680.pdf Draft Intrauterine Intrauterine Device 018680 11/2019
Copper Dotatate Cu-64 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213227.pdf Draft Intravenous Solution 213227 08/2021
Crisaborole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Crisaborole-NDA-207695.pdf Draft Topical Ointment 207695 02/2019
Crizotinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/Crizotinib_Caps_202570_RC07-14.pdf Draft Oral Capsule 202570 07/2014
Crofelemer https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202292.pdf Draft Oral Tablet, Delayed Release 202292 11/2020
Crotamiton https://www.accessdata.fda.gov/drugsatfda_docs/psg/Crotamiton_topical lotion_RLD 009112_RC09-16.pdf Draft Topical Lotion 009112 10/2016
Crotamiton https://www.accessdata.fda.gov/drugsatfda_docs/psg/Crotamiton_topical cream_RLD 006927_RC09-16.pdf Draft Topical Cream 006927 10/2016
Cyanocobalamin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyanocobalamin_nasal metered spray_NDA 021642_RC05-17.pdf Draft Nasal Spray 021642 07/2017
Cyclobenzaprine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclobenzaprine HCl_oral tablet _RLD 17821_final 08-17.pdf Final Oral Tablet 017821 08/2017
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 11/2016
Cyclophosphamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclophosphamide_oral capsule_203856_RC06-15.pdf Draft Oral Capsule 203856 06/2015
Cyclophosphamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclophosphamide_oral tablet_040032_RV09-15.pdf Draft Oral Tablet 040032 09/2015
Cycloserine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cycloserine_oral capsule_RLD 060593_Final 08-17.pdf Final Oral Capsule 060593 08/2017
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine_Oral capsule_RLD 050625_RV04-16.pdf Draft Oral Capsule 050625 04/2016
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine_Oral capsule_RLD 050715_RV04-16.pdf Draft Oral Capsule 050715 04/2016
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyclosporine_ophthalmic emulsion_RLD 050790_RV09-16.pdf Draft Ophthalmic Emulsion 050790 10/2016
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214965.pdf Draft Ophthalmic Emulsion 214965 08/2022
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 05/2019
Cyproheptadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Cyproheptadine hydrochloride_Oral tablet_087056_RC06-15.pdf Draft Oral Tablet 012649 06/2015
Cysteamine Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213491.pdf Draft Oral Granule, Delayed Release 213491 03/2021
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 02/2018
Cytarabine; Daunorubicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209401.pdf Draft Intravenous Powder 209401 08/2022

Newly Added Guidances since August 2022

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acetaminophen; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211733.pdf Draft Oral Tablet 211733 08/2022
Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210526.pdf Draft Oral Tablet, Extended Release 210526 08/2022
Ampicillin/Ampicillin Trihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_064082.pdf Draft Oral Capsule 064082 08/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213872.pdf Draft Nasal Spray, Metered 213872 08/2022
Berotralstat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214094.pdf Draft Oral Capsule 214094 08/2022
Cabotegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212887.pdf Draft Oral Tablet 212887 08/2022
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018281.pdf Draft Oral Tablet, Chewable 018281 08/2022
Caspofungin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021227.pdf Draft Intravenous Powder 021227 08/2022
Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210455.pdf Draft Oral Tablet 210455 08/2022
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214965.pdf Draft Ophthalmic Emulsion 214965 08/2022
Cytarabine; Daunorubicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209401.pdf Draft Intravenous Powder 209401 08/2022
Dasiglucagon Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214231.pdf Draft Subcutaneous Solution 214231 08/2022
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050751.pdf Draft Periodontal System, Extended Release 050751 08/2022
Etonogestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021529.pdf Draft Implantation Implant 021529 08/2022
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020801.pdf Draft Oral Tablet, Chewable 020801 08/2022
Gallium Ga-68 Gozetotide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212642.pdf Draft Intravenous Solution 212642 212643 08/2022
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020601.pdf Draft Oral Tablet, Chewable 020601 08/2022
Ketoprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018754.pdf Draft Oral Capsule 018754 08/2022
Lonafarnib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213969.pdf Draft Oral Capsule 213969 08/2022
Loperamide Hydrochloride; Simethicone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020606.pdf Draft Oral Tablet, Chewable 020606 08/2022
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210933.pdf Draft Ophthalmic Suspension/Drops 210933 08/2022
Mometasone Furoate; Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211746.pdf Draft Nasal Spray, Metered 211746 08/2022
Nifurtimox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213464.pdf Draft Oral Tablet 213464 08/2022
Pafolacianine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214907.pdf Draft Intravenous Solution 214907 08/2022
Relugolix https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214621.pdf Draft Oral Tablet 214621 08/2022
Setmelanotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213793.pdf Draft Subcutaneous Solution 213793 08/2022
Technetium Tc-99m Sodium Pertechnetate Generator https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202158.pdf Draft Intravenous, Intravesicular, Ophthalmic Solution 202158 08/2022
Vericiguat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214377.pdf Draft Oral Tablet 214377 08/2022
Vibegron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213006.pdf Draft Oral Tablet 213006 08/2022

Newly Revised Guidances since August 2022

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050726.pdf Draft Oral Tablet, Chewable 050726 08/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020114.pdf Draft Nasal Spray, Metered 020114 08/2022
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021621.pdf Draft Oral Tablet, Chewable 021621 08/2022
Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205579.pdf Draft Intravenous For Suspension 205579 08/2022
Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021490.pdf Draft Oral Tablet 021490 202086 08/2022
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203667.pdf Draft Oral Tablet 203667 08/2022
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020764.pdf Draft Oral Tablet, For Suspension 020764 08/2022
Lanthanum Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021468.pdf Draft Oral Tablet, Chewable 021468 08/2022
Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021891.pdf Draft Oral Tablet, Chewable 021891 08/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012541.pdf Draft Injection Injectable 012541 08/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020246.pdf Draft Injection Injectable 020246 08/2022
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 08/2022
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021475.pdf Draft Oral Tablet, Chewable 021475 08/2022
Nicotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020385.pdf Draft Nasal Spray, Metered 020385 08/2022
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021861.pdf Draft Nasal Spray, Metered 021861 08/2022
Oxymetazoline Hydrochloride; Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208032.pdf Draft Nasal Spray, Metered 208032 08/2022
Prednisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202020.pdf Draft Oral Tablet, Delayed Release 202020 08/2022
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210115.pdf Draft Oral For Suspension 210115 08/2022
Upadacitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211675.pdf Draft Oral Tablet, Extended Release 211675 08/2022
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