Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to, the filenames for product-specific guidances on this web page may not match the corresponding guidance titles. In such cases, the name on the document correctly identifies the title of the guidance. These discrepancies will be corrected as soon as possible.

To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use; bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug.

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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).

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

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

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

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

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

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

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 website ( 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 Help Desk at 1-877-378-5457 (toll free) for assistance regarding submissions.

The FDA posts plans for issuing new or revised product-specific guidances on the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page.

For additional information on development of generic drug products, please refer to FDA’s biopharmaceutics guidances.

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




Total number of currently published PSGs: 1921

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

194 record(s) found for 'C'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Cabozantinib S Malate S-malate_oral capsules_NDA 203756_RC11-17.pdf Draft Oral Capsule 203756 02/2018
Cabozantinib S malate S-Malate_oral tablet_NDA 208692_RC11-17.pdf Draft Oral Tablets 208692 02/2018
Calcifediol Draft Oral Capsule, Extended Release 208010 03/2021
Calcipotriene Draft Topical Aerosol, Foam 022563 11/2020
Calcipotriene Topical Emulsion Cream NDA 020554 RV Feb 2019.pdf Draft Topical Cream 020554 02/2019
Calcipotriene Topical Ointment NDA 020273 RV Feb 2019.pdf Draft Topical Ointment 020273 02/2019
Calcipotriene Draft Topical Solution 020611 08/2010
Calcitonin Salmon Draft Nasal Spray, Metered 020313 03/2020
Calcitriol _18044_RC7-08.pdf Draft Oral Capsule 018044 09/2010
Calcium Acetate acetate_oral tablet_ANDA 078502_RV03-17.pdf Draft Oral Tablet 019976 05/2017
Calcium Acetate acetate_oral capsule_RLD 021160_RV03-17.pdf Draft Oral Capsule 021160 05/2017
Calcium Carbonate; Famotidine; Magnesium Hydroxide carbonate_Famotidine_Magnesium hydroxide_Oral tablet_020958_RC06-15.pdf Draft Oral Tablet, Chewable 020958 06/2015
Calcium Carbonate;Risedronate Sodium Final Oral Tablet, Tablet 021823 05/2008
Canagliflozin Draft Oral Tablet 204042 07/2014
Canagliflozin; Metformin Hydrochloride; Metformin HCl_oral ER tablet_NDA 205879_RC08-17.pdf Draft Oral Tablet, Extended Release 205879 10/2017
Canagliflozin; Metformin Hydrochloride and Metformin HCl_oral tablet_204353_RC06-15.pdf Draft Oral Tablet 204353 06/2015
Candesartan Cilexetil Final Oral Tablet 020838 05/2008
Candesartan Cilexetil; Hydrochlorothiazide _RC8-04.pdf Draft Oral Tablet 021093 09/2008
Cannabidiol Draft Oral Solution 210365 03/2021
Capecitabine Draft Oral Tablet 020896 09/2012
Capsaicin Draft Topical Patch 022395 11/2019
Captopril tablet_RLD 074434_RC09-16.pdf Draft Oral Tablet 018343 10/2016
Carbamazepine tablet_016608_RV09-15.pdf Draft Oral Tablet 016608 09/2015
Carbamazepine tab_020234_RV03-15.pdf Draft Oral Tablet, Extended Release 020234 03/2015
Carbamazepine ER cap_20712_RV03-15.pdf Draft Oral Capsule, Extended Release 020712 021710 03/2015
Carbamazepine suspension_18927_RV03-15.pdf Draft Oral Suspension 018927 03/2015
Carbidopa Draft Oral Tablet 017830 07/2014
Carbidopa; Entacapone; Levodopa Draft Oral Tablet 021485 06/2013
Carbidopa; Levodopa; Levedopa_enteral suspension_RLD 203952_RC03-17.pdf Draft Enteral Suspension 203952 05/2017
Carbidopa; Levodopa; Levodopa_oral tablet_RLD 17555_RC09-16.pdf Draft Oral Tablet 017555 10/2016
Carbidopa; Levodopa; Levodopa_oral ER capsule_203312_RC09-15.pdf Draft Oral Capsule, Extended Release 203312 09/2015
Carbidopa; Levodopa Draft Oral Tablet, Extended Release 019856 09/2012
Carbidopa; Levodopa;_Levodopa_ODtab_76699_RC2-10.pdf Draft Oral Tablet, Orally Disintegrating 078893 02/2010
Carbinoxamine Maleate Draft Oral Suspension, Extended Release 022556 07/2014
Carbinoxamine Maleate Draft Oral Tablet 008915 08/2021
Carglumic Acid Draft Oral Tablet 022562 06/2020
Cariprazine Hydrochloride Draft Oral Capsule 204370 11/2019
Carisoprodol Draft Oral Tablet 011792 03/2010
Carvedilol Final Oral Tablet 020297 05/2008
Carvedilol Phosphate Draft Oral Capsule, Extended Release 022012 02/2010
Cefaclor Draft Oral Capsule 050521 02/2011
Cefaclor Draft Oral Tablet, Extended Release 050673 11/2019
Cefadroxil; Cefadroxil Hemihydrate;_Cefadroxil_Hemihydrate_65282_RC09-10.pdf Draft Oral Capsule 050512 09/2010
Cefdinir Draft Oral Capsule 050739 01/2008
Cefdinir powder for suspension_ NDA 050749_RC05-17.pdf Draft Oral Powder For Suspension 050749 07/2017
Cefditoren Pivoxil 21222_RV3-10 minor edit after post.pdf Final Oral Tablet 021222 11/2015
Cefiderocol Sulfate Tosylate Draft Intravenous Powder 209445 08/2021
Cefixime RC07-14.pdf Draft Oral Tablet, Chewable 065380 07/2014
Cefixime Draft Oral Capsule 203195 04/2013
Cefixime Draft Oral Tablet 050621 02/2011
Cefixime Draft Oral Suspension 202091 11/2013
Cefpodoxime Proxetil Draft Oral Suspension 050675 06/2012
Cefpodoxime Proxetil Draft Oral Tablet 050674 06/2012
Cefprozil Draft Oral Suspension 050665 06/2012
Cefprozil Draft Oral Tablet 050664 06/2012
Cefuroxime Axetil Draft Oral Tablet 050605 08/2010
Cefuroxime Axetil Draft Oral Suspension 050672 02/2010
Celecoxib Draft Oral Capsule 020998 11/2013
Cephalexin suspension_RLD 062703_RC12-16.pdf Draft Oral Suspension 050406 12/2016
Cephalexin Final Oral Capsule 050405 10/2011
Ceritinib Oral Capsule NDA 205755 RV Feb 2019.pdf Draft Oral Capsule 205755 02/2019
Ceritinib Draft Oral Tablet 211225 11/2020
Cetirizine Hydrochloride Final Oral Tablet, Chewable 021621 05/2008
Cetirizine Hydrochloride Draft Oral Tablet, Orally Disintegrating 022578 06/2012
Cetirizine Hydrochloride hydrochloride_oral tablet_RLD 019835_RC12-16.pdf Draft Oral Tablet 019835 12/2016
Cetirizine Hydrochloride HCl_oral capsule_RLD 022429_Final 08-17.pdf Final Oral Capsule 022429 08/2017
Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride;_Pseudoephedrine_HCl_ERtab_21150_RC2-08.pdf Draft Oral Tablet, Extended Release 021150 02/2008
Cevimeline Hydrochloride Final Oral Capsule 020989 05/2008
Chenodiol Draft Oral Tablet 018513 09/2019
Chlorambucil Draft Oral Tablet 010669 07/2010
Chlordiazepoxide Hydrochloride Draft Oral Capsule 012249 09/2019
Chlordiazepoxide Hydrochloride; Clidinium Bromide clindinium_oral capsule_RLD 012750_RC03-17.pdf Draft Oral Capsule 012750 05/2017
Chloroquine Phosphate Final Oral Tablet 006002 04/2020
Chlorothiazide Oral Suspension NDA 011870 PSG Page RC Feb 2019.pdf Draft Oral Suspension 011870 02/2019
Chlorpheniramine Maleate Draft Oral Tablet, Extended Release 007638 09/2019
Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride HCltablet022113RC03_15.pdf Draft Oral Tablet 022113 03/2015
Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride 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 Draft Oral Suspension, Extended Release 207768 04/2016
Chlorpheniramine Polistirex; Hydrocodone Polistirex;_Hydrocodone_Polistirex_susp_19111_RC2-10.pdf Draft Oral Suspension, Extended Release 019111 02/2010
Chlorpheniramine Polistirex; Hydrocodone Polistirex;_ Hydrocodone_Plistirex_ERcap_77273_RC12-08.pdf Draft Oral Capsule, Extended Release 077273 12/2008
Chlorpromazine Hydrochloride Hydrochloride Oral Tablet ANDA 84114 RV 09-2018.pdf Draft Oral Tablet 084112 084114 09/2018
Chlorpromazine Hydrochloride Draft Oral Concentrate 009149 09/2019
Chlorthalidone Draft Oral Tablet 50 mg; 25 mg 012283 09/2019
Chlorthalidone Draft Oral Tablet 25 mg; 15 mg 019574 09/2019
Chlorzoxazone Draft Oral Tablet 750 mg 011529 11/2019
Chlorzoxazone Draft Oral Tablet 011300 11/2019
Chlorzoxazone Draft Oral Tablet 500 mg 011529 11/2019
Cholestyramine powder_74557 and 74558_RV06-15.pdf Draft Oral Powder 016640 019669 06/2015
Cholic Acid acidz_oral capsule_RLD 205750_RC03-16.pdf Draft Oral Capsule 205750 10/2016
Choline Fenofibrate of Choline_Fenofibrate_DRtabs_22224_RC12-10.pdf Draft Oral Capsule, Delayed Release 022224 12/2010
Ciclesonide Nasal Aerosol 202129 RC09-12.pdf Draft Nasal Aerosol, Metered 202129 09/2012
Ciclesonide Draft Inhalation Aerosol, Metered 021658 03/2021
Ciclopirox Topical Suspension NDA 019824 RV Feb 2019.pdf Draft Topical Suspension 019824 02/2019
Ciclopirox Topical Cream NDA 018748 RV Feb 2019.pdf Draft Topical Cream 018748 02/2019
Ciclopirox Topical Gel NDA 020519 RV Feb 2019.pdf Draft Topical Gel 020519 02/2019
Ciclopirox Draft Topical Shampoo 021159 02/2010
Ciclopirox RC2-10.pdf Draft Topical Solution 021022 02/2011
Cilastatin Sodium; Imipenem; Relebactam Draft Intravenous Powder 212819 07/2021
Cilostazol Final Oral Tablet 020863 05/2008
Cinacalcet Hydrochloride Final Oral Tablet 021688 05/2008
Ciprofloxacin Final Oral Suspension 020780 10/2011
Ciprofloxacin susp injec_RLD 207986_RC07-18.pdf Draft Otic Suspension, Injectable 207986 07/2018
Ciprofloxacin hydrochloride ointment_RLD_020369_RC09-18.pdf Draft Ophthalmic Ointment 020369 09/2018
Ciprofloxacin Hydrochloride hydrochloride_ophthalmic solution_NDA 019992_RV08-17.pdf Draft Ophthalmic Drops, Solution 019992 10/2017
Ciprofloxacin Hydrochloride Draft Oral Tablet 019537 09/2010
Ciprofloxacin Hydrochloride Draft Oral Tablet, Extended Release 021744 11/2007
Ciprofloxacin Hydrochloride; Hydrocortisone HCL_Hydrocortisone_Otic susp_RLD 020805_RV01-16.pdf Draft Otic Suspension, Drops 020805 01/2016
Ciprofloxacin; Ciprofloxacin Hydrochloride; Ciprofloxacin Hydrochloride_ERtab_21473_RC1-08.pdf Draft Oral Tablet, Extended Release 021473 01/2008
Ciprofloxacin; Dexamethasone suspension_RLD 021537_RV04-16.pdf Draft Otic Suspension, Drops 021537 04/2016
Citalopram Hydrobromide hydrobromide_Oral Capsule_RLD 77668_Final 08-17.pdf Final Oral Capsule 077668 08/2017
Citalopram Hydrobromide hydrobromide_Oral Tablet_RLD 20822_Final 08-17.pdf Final Oral Tablet 020822 08/2017
Clarithromycin Tablet_RLD 50662_Final 08-17.pdf Final Oral Tablet 050662 08/2017
Clarithromycin Draft Oral Tablet, Extended Release 050775 01/2008
Clarithromycin Final Oral Suspension 050698 05/2008
Clemastine Fumarate Draft Oral Tablet 2.68 mg 017661 09/2019
Clemastine Fumarate Draft Oral Tablet 1.34 mg 020925 09/2019
Clevidipine Draft Intravenous Emulsion 022156 03/2020
Clindamycin Hydrochloride HCl_Oral Capsule_RLD 50162_Final 08-17.pdf Final Oral Capsule 050162 08/2017
Clindamycin Phosphate Draft Vaginal Cream 050680 03/2012
Clindamycin Phosphate Draft Vaginal Cream 050793 03/2012
Clindamycin Phosphate Draft Vaginal Suppository 050767 03/2012
Clindamycin Phosphate Draft Topical Gel 050615 11/2019
Clindamycin Phosphate Draft Topical Lotion 050600 11/2019
Clindamycin Phosphate Draft Topical Solution 050537 06/2020
Clindamycin Phosphate Draft Topical Swab 050537 06/2020
Clindamycin Phosphate Draft Topical Gel 050782 06/2020
Clindamycin Phosphate Draft Topical Aerosol, Foam 050801 06/2020
Clindamycin Phosphate; Tretinoin Draft Topical Gel 050802 06/2020
Clindamycin Phosphate; Tretinoin Draft Topical Gel 050803 06/2020
Clobazam Draft Oral Film 210833 11/2020
Clobazam Draft Oral Suspension 203993 04/2014
Clobazam Draft Oral Tablet 202067 11/2013
Clobetasol Propionate Propionate_Emollient Cream 0.05_RLD 75430_RC09-16.pdf Draft Topical Cream 020340 10/2016
Clobetasol Propionate Propionate_topical gel 0.05_RLD 75368_RC09-16.pdf Draft Topical Gel 020337 10/2016
Clobetasol Propionate propionate_topical cream_RLD 74220_RC04-16.pdf Draft Topical Cream 019322 04/2016
Clobetasol Propionate propionate_topical lotion_RLD 21535_RC04-16.pdf Draft Topical Lotion 021535 04/2016
Clobetasol Propionate Draft Topical Foam, Aerosol 021142 02/2011
Clobetasol Propionate Draft Topical Shampoo 021644 02/2011
Clobetasol Propionate Draft Topical Spray 021835 02/2011
Clobetasol Propionate Draft Topical Solution 019966 08/2010
Clobetasol Propionate propionate_topical ointment_RLD 019323_RC01-16.pdf Draft Topical Ointment 019323 01/2016
Clobetasol Propionate Draft Topical Aerosol, Foam 022013 11/2020
Clocortolone Pivalate pivalate_topical cream_ NDA 017765_RC05-17.pdf Draft Topical Cream 017765 07/2017
Clomiphene Citrate citrate_Oral tablet_RLD 16131_Final 08-17.pdf Final Oral Tablet 016131 08/2017
Clomipramine Hydrochloride hydrochloride_oral capsule_019906_RC09-15.pdf Draft Oral Capsule 019906 09/2015
Clonazepam disintegrating tablet_ANDA 077171_RC03-17.pdf Draft Oral Tablets, Disintegrating 020813 05/2017
Clonazepam Tablet_RLD 17533_Final 08-17.pdf Final Oral Tablet 017533 08/2017
Clonidine Draft Oral Tablet, Extended Release 022500 08/2010
Clonidine Draft Transdermal Film, Extended Release 018891 11/2019
Clonidine Hydrochloride hydrochloride_oral tablet_022331_RC09-15.pdf Draft Oral Tablet, Extended Release 022331 09/2015
Clonidine Hydrochloride Draft Oral Tablet 017407 11/2019
Clopidogrel Bisulfate Draft Oral Tablet 020839 08/2008
Clorazepate Dipotassium Draft Oral Tablet 017105 12/2012
Clotrimazole Topical Solution NDA 018181 RV Feb 2019.pdf Draft Topical Solution 018181 02/2019
Clotrimazole Topical Cream ANDA 072640 RV Feb 2019.pdf Draft Topical Cream 072640 02/2019
Clotrimazole Vaginal Cream NDA 018052 RV Feb 2019.pdf Draft Vaginal Cream 018052 02/2019
Clotrimazole Vaginal Cream NDA 020574 RV Feb 2019.pdf Draft Vaginal Cream 020574 02/2019
Clotrimazole Vaginal Tablet NDA 017717 RV Feb 2019.pdf Draft Vaginal Tablet 017717 02/2019
Clotrimazole Vaginal Tablet NDA 020525 RV Feb 2019.pdf Draft Vaginal Tablet 020525 02/2019
Clotrimazole Draft Oral Troche/Lozenge 018713 09/2008
Clozapine suspension_RLD 203479_RC12-16.pdf Draft Oral Suspension 203479 12/2016
Clozapine Final Oral Tablet 019758 03/2011
Clozapine Disintigrating Tablet_RLD 021590_Final 08-17.pdf Final Oral Tablet, Orally Disintegrating 021590 08/2017
Cobicistat tablet_203094_RC09-15.pdf Draft Oral Tablet 203094 09/2015
Cobicistat; Darunavir; Darunavir ethanolate_oral tablet_RLD 205395_RV12-16.pdf Draft Oral Tablet 205395 12/2016
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate; ElviteNDA 207561_RV08-17.pdf Draft Oral Tablet 207561 10/2017
Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate Draft Oral Tablet 203100 12/2014
Cobimetinib Fumarate Fumarate _oral tablet_RLD 206192_RC06-16.pdf Draft Oral Tablet 206192 06/2016
Cocaine Hydrochloride Draft Nasal Solution 209963 12/2019
Colchicine capsule_RLD 204820_RC12-16.pdf Draft Oral Capsule 204820 12/2016
Colchicine Draft Oral Tablet 022352 09/2010
Colesevelam Hydrochloride hydrochloride_oral tablet_021176_RV09-15.pdf Draft Oral Tablet 021176 09/2015
Colesevelam Hydrochloride Draft Oral For Suspension 022362 09/2019
Colestipol Hydrochloride Draft Oral Tablet 020222 07/2014
Copper Draft Intrauterine Intrauterine Device 018680 11/2019
Copper Dotatate Cu-64 Draft Intravenous Solution 213227 08/2021
Crisaborole Draft Topical Ointment 207695 02/2019
Crizotinib Draft Oral Capsule 202570 07/2014
Crofelemer Draft Oral Tablet, Delayed Release 202292 11/2020
Crotamiton cream_RLD 006927_RC09-16.pdf Draft Topical Cream 006927 10/2016
Crotamiton lotion_RLD 009112_RC09-16.pdf Draft Topical Lotion 009112 10/2016
Cyanocobalamin metered spray_NDA 021642_RC05-17.pdf Draft Nasal Spray 021642 07/2017
Cyclobenzaprine Hydrochloride HCl_oral tablet _RLD 17821_final 08-17.pdf Final Oral Tablet 017821 08/2017
Cyclobenzaprine Hydrochloride HCL_oral ER capsule_RLD 21777_RV12-16.pdf Draft Oral Capsule, Extended Release 021777 11/2016
Cyclophosphamide tablet_040032_RV09-15.pdf Draft Oral Tablet 040032 09/2015
Cyclophosphamide capsule_203856_RC06-15.pdf Draft Oral Capsule 203856 06/2015
Cycloserine capsule_RLD 060593_Final 08-17.pdf Final Oral Capsule 060593 08/2017
Cyclosporine capsule_RLD 050625_RV04-16.pdf Draft Oral Capsule 050625 04/2016
Cyclosporine capsule_RLD 050715_RV04-16.pdf Draft Oral Capsule 050715 04/2016
Cyclosporine emulsion_RLD 050790_RV09-16.pdf Draft Ophthalmic Emulsion 050790 10/2016
Cyclosporine ophthalmic solution 0.09 NDA 210913 PSG Page RC May 2019.pdf Draft Ophthalmic Drops, Solution 210913 05/2019
Cyproheptadine Hydrochloride hydrochloride_Oral tablet_087056_RC06-15.pdf Draft Oral Tablet 012649 06/2015
Cysteamine Bitartrate bitartrate_oral DR capsule_NDA 203389_RV11-17.pdf Draft Oral Capsule, Delayed Release 203389 02/2018
Cysteamine Bitartrate Draft Oral Granule, Delayed Release 213491 03/2021

Newly Added Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acyclovir Draft Ophthalmic Ointment 202408 08/2021
Albuterol Sulfate; Ipratropium Bromide Draft Inhalation Spray, Metered 021747 08/2021
Amisulpride Draft Intravenous Solution 209510 08/2021
Avapritinib Draft Oral Tablet 212608 08/2021
Carbinoxamine Maleate Draft Oral Tablet 008915 08/2021
Cefiderocol Sulfate Tosylate Draft Intravenous Powder 209445 08/2021
Copper Dotatate Cu-64 Draft Intravenous Solution 213227 08/2021
Esomeprazole Magnesium Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Estradiol Draft Transdermal Gel, Metered 021166 08/2021
Ethinyl Estradiol; Levonorgestrel Draft Transdermal System 204017 08/2021
Fostemsavir Tromethamine Draft Oral Tablet, Extended Release 212950 08/2021
Indomethacin Draft Rectal Suppository 017814 08/2021
Ipratropium Bromide Draft Nasal Spray, Metered 020393 020394 08/2021
Lasmiditan Succinate Draft Oral Tablet 211280 08/2021
Leuprolide Acetate Draft Subcutaneous Powder 021343 08/2021
Loteprednol Etabonate Draft Ophthalmic Gel 208219 08/2021
Olodaterol Hydrochloride Draft Inhalation Spray, Metered 203108 08/2021
Osilodrostat Phosphate Draft Oral Tablet 212801 08/2021
Ozanimod Hydrochloride Draft Oral Capsule 209899 08/2021
Paliperidone Palmitate Draft Intramuscular Suspension, Extended Release 207946 08/2021
Semaglutide Draft Oral Tablet 213051 08/2021
Sufentanil Citrate Draft Sublingual Tablet 209128 08/2021
Tazemetostat Hydrobromide Draft Oral Tablet 211723 08/2021

Newly Revised Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Bexarotene Draft Oral Capsule 021055 08/2021
Budesonide Draft Oral Capsule, Delayed Release 021324 08/2021
Eltrombopag Olamine Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine Draft Oral For Suspension 207027 08/2021
Ferric Citrate Draft Oral Tablet 205874 08/2021
Ferric Oxyhydroxide Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide Draft Intravenous Injectable 021135 09/2021
Letrozole Draft Oral Tablet 020726 08/2021
Leuprolide Acetate Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate Draft Injection Injectable 020517 020708 08/2021
Liothyronine Sodium Draft Oral Tablet 010379 08/2021
Loteprednol Etabonate Draft Ophthalmic Suspension/Drops 020583 08/2021
Nystatin Draft Topical Powder 065203 08/2021
Orlistat Draft Oral Capsule 020766 021887 08/2021
Paclitaxel Draft IV Infusion For Suspension 021660 08/2021
Podofilox Draft Topical Gel 020529 08/2021
Sodium Zirconium Cyclosilicate Draft Oral For Suspension 207078 08/2021
Tazarotene Draft Topical Cream 0.05% 021184 08/2021

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