Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to www.fda.gov, 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 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 (https://www.regulations.gov/help). 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) 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


172 record(s) found for 'D'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Dabigatran Etexilate Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dabigatran etexilate mesylate_oral capsule_NDA 022512_RV05-17.pdf Draft Oral Capsule 022512 07/2017
Dabrafenib Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dabrafenib mesylate_oral capsule_202806_RC06-15.pdf Draft Oral Capsule 202806 06/2015
Daclatasvir Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Daclatasvir dihydrochloride_oral tablet_NDA 206843_RV11-17.pdf Draft Oral Tablet 206843 02/2018
Dacomitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211288.pdf Draft Oral Tablet 211288 03/2020
Dalfampridine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dalfampridine_ERtab_22250_RC03-12.pdf Draft Oral Tablet, Extended Release 022250 03/2012
Dalteparin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dalteparin_Inj_20287_RC09-12.pdf Draft Subcutaneous Injectable 020287 09/2012
Danazol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Danazol_cap_74582_RC10-05.pdf Final Oral Capsule 074582 05/2008
Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dantrolene sodium_intravenous suspension_NDA 205579_RC08-17.pdf Draft Intravenous Suspension 205579 10/2017
Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017443.pdf Draft Oral Capsule 017443 09/2019
Dapagliflozin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202293.pdf Draft Oral Tablet 202293 06/2020
Dapagliflozin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205649.pdf Draft Oral Tablet, Extended Release 205649 03/2020
Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210874.pdf Draft Oral Tablet, Extended Release 210874 03/2020
Dapagliflozin; Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209091.pdf Draft Oral Tablet 209091 06/2020
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207154.pdf Draft Topical Gel 207154 11/2019
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dapsone_oral tablet_ANDA 086842_Final 08-17.pdf Final Oral Tablet 086841 086842 08/2017
Dapsone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021794.pdf Draft Topical Gel 021794 11/2019
Daptomycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/DAPTOMYCIN IV infusion powder NDA 209949 & NDA 208385 Page Feb 2019.pdf Draft IV Infusion Powder 209949 208385 02/2019
Darifenacin Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Darifenacin_HBr_ERtab_21513_RC8-05.pdf Final Oral Tablet, Extended Release 021513 05/2008
Darolutamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212099.pdf Draft Oral Tablet 212099 08/2020
Darunavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Darunavir_Ethanolate_tab_21976_RV04-13.pdf Draft Oral Tablet 021976 04/2013
Darunavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Darunavir_ethanolate_susp_202895_RC12-14.pdf Draft Oral Suspension 202895 12/2014
Dasabuvir Sodium; Ombitasvir; Paritaprevir; Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/DasabuvirNa; Ombitasvir; Paritaprevir; Ritonavir_RC05-17.pdf Draft Oral Tablets, Extended Release 208624 07/2017
Dasabuvir Sodium;Ombitasvir;Paritaprevir;Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Obitasvir_paritaprevir_ritonavir_dasabuvir_oral tablet_206619_RC09-15.pdf Draft Oral Tablet, Tablet 206619 09/2015
Dasatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021986.pdf Draft Oral Tablet 021986 05/2021
Daunorubicin Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Daunorubicin citrate_lipoinj_50704 RC07-14.pdf Draft Injection Injectable, Liposomal 050704 07/2014
Deferasirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_oral tablet_RLD 206910_RC04-16.pdf Draft Oral Tablet 206910 04/2016
Deferasirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_susp_21882_RC5-06.pdf Final Oral Tablet, For Suspension 021882 05/2008
Deferasirox https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferasirox_draft_Oral gran_RLD 207968_RC07-18.pdf Draft Oral Granules 207968 07/2018
Deferiprone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deferiprone_oral tablet_RLD 021825_RV03-17.pdf Draft Oral Tablet 021825 05/2017
Deflazacort https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deflazacort_oral suspension_NDA 208685_RC08-17.pdf Draft Oral Suspension 208685 10/2017
Deflazacort https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deflazacort_oral tablet_NDA 208684_RC08-17.pdf Draft Oral Tablet 208684 10/2017
Degarelix Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022201.pdf Draft Subcutaneous Powder 022201 03/2021
Delafloxacin meglumine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Delafloxacin meglumine_draft_Oral tab_RLD 208610_RC09-18.pdf Draft Oral Tablet 208610 09/2018
Delavirdine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Delavirdine_Mesylate 20705_RC11-07.pdf Draft Oral Tablet 020705 11/2007
Demeclocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Demeclocycline_HCl_tab_50261_RC10-08.pdf Draft Oral Tablet 050261 10/2008
Desipramine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desipramine HCl_ oral tablet_ RLD 14399_Final 08-17.pdf Final Oral Tablet 014399 08/2017
Desloratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desloratadine_ODtab_21312_RC12-05.pdf Final Oral Tablet, Orally Disintegrating 021312 05/2008
Desloratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desloratadine_tab_21165_RC10-05.pdf Final Oral Tablet 021165 05/2008
Desloratadine; Pseudoephedrine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desloratadine_Pseudoephedrine_Oral_Extended_Release_Tablet_NDA_021313_PSG_Page_RC_May_2019.pdf Draft Oral Tablet, Extended Release 021313 05/2019
Desmopressin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desmopressin acetate Sublingual Tablets NDA 022517 PSG Page RC May 2019.pdf Draft Sublingual Tablet 022517 05/2019
Desmopressin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desmopressin acetate_ oral tablet_ RLD19955_Final 08-17.pdf Final Oral Tablet 019955 08/2017
Desogestrel; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desogestrel;_Ethiny_ Estradiol_tab_20301_RC4-09.pdf Draft Oral Tablet 020301 03/2010
Desogestrel; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desogestrel;_Ethinyl_Estradiol_(Cyclessa)_21090_RC3-09.pdf Draft Oral Tablet 021090 03/2009
Desogestrel; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desogestrel;_EE _(mircette)_tab_20713_RC8-08.pdf Draft Oral Tablet 020713 07/2009
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical ointment_RLD 017426_RC09-16.pdf Draft Topical Ointment 017426 10/2016
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical cream_RLD 017010_RC01-16.pdf Draft Topical Cream 017010 01/2016
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_topical lotion_RLD 072354_RC01-16.pdf Draft Topical Lotion 072354 01/2016
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desonide_draft_Topical gel_RLD 021844_RC09-18.pdf Draft Topical Gel 021844 09/2018
Desonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021978.pdf Draft Topical Aerosol, Foam 021978 11/2020
Desoximetasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desoximetasone_topical spray 0.25_204141_RC03-15.pdf Draft Topical Spray 204141 03/2015
Desoximetasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desoximetasone_cream_073210_073193_RC02-14.pdf Draft Topical Cream 017856 018309 04/2014
Desoximetasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Desoximetasone_ointment_18594_74286_RC02-14.pdf Draft Topical Ointment 018594 018763 04/2014
Desvenlafaxine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204683.pdf Draft Oral Tablet, Extended Release 204683 06/2020
Desvenlafaxine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204150.pdf Draft Oral Tablet, Extended Release 204150 06/2020
Desvenlafaxine Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205583.pdf Draft Oral Tablet, Extended Release 205583 06/2020
Desvenlafaxine Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021992.pdf Draft Oral Tablet, Extended Release 021992 06/2020
Deutetrabenazine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Deutetrabenazine_draft_Oral tab_RLD 208082_RC09-18.pdf Draft Oral Tablet 208082 09/2018
Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone Oral Concentrate Solution ANDA 088252 RC Feb 2019.pdf Draft Oral Concentrate 088252 02/2019
Dexamethasone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone_tabs_88316_84612_87916_88306_84610_84613_84611_RC06-11.pdf Draft Oral Tablet 011664 06/2011
Dexamethasone; Neomycin sulfate; Polymyxin B sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone; Neomycin sulfate; Polymyxin B sulfate_draft_Ophthalmic susp drops_RLD 050023_RC07-18.pdf Draft Ophthalmic Suspension, Drops 050023 07/2018
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone; Tobramycin_ophthalmic ointment_RLD 050616_RV06-16.pdf Draft Ophthalmic Ointment 050616 06/2016
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone Tobramycin_ophthalmic suspension NDA 50818 RV Feb 2019.pdf Draft Ophthalmic Suspension 050818 02/2019
Dexamethasone; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexamethasone; Tobramycin_ophthalmic suspension NDA 50592 RV Feb 2019.pdf Draft Ophthalmic Suspension 050592 02/2019
Dexbrompheniramine Maleate; Pseudoephedrine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexbrompheniramine maleate Pseudoephedrine sulfate_078648_RC06-15.pdf Draft Oral Tablet, Extended Release 013483 06/2015
Dexlansoprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexlansoprazole_orally disintegrating DR tablet_NDA 208056_RV11-17.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 208056 02/2018
Dexlansoprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexlansoprazole_oral DR capsule_NDA 022287_RV11-17.pdf Draft Oral Capsule, Delayed Release 022287 02/2018
Dexmethylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexmethylphenidate_tab_21278_RC2-08.pdf Draft Oral Tablet 021278 02/2008
Dexmethylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dexmethylphenidate HCL_Oral ER cap_21802_RV03-15.pdf Draft Oral Capsule, Extended Release 021802 03/2015
Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextroamphetamine Sulfate_Oral ER Cap_017078_RV03-15.pdf Draft Oral Capsule, Extended Release 017078 03/2015
Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextroamphetamine sulfate_oral tablet_ANDA 040361_RC05-17.pdf Draft Oral Tablet 040361 07/2017
Dextromethorphan Hydrobromide; Guaifenesin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextromethorphan_Hydrobromide;_Guaifenesin_ERtab_21620_RC12-08.pdf Draft Oral Tablet, Extended Release 021620 12/2008
Dextromethorphan Hydrobromide; Quinidine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextromethorphan_Quinidine_cap_021879_RV04-13.pdf Draft Oral Capsule 021879 04/2013
Dextromethorphan Polistirex https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dextromethorphan_Polistirex_ERsusp_18658_RC10-05.pdf Final Oral Suspension, Extended Release 018658 05/2008
Diazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazepam_Rectal_gel_20648_RC08-10.pdf Draft Rectal Gel 020648 07/2010
Diazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazepam_draft_Oral tab_RLD 013263_RC09-18.pdf Draft Oral Tablet 013263 09/2018
Diazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211635.pdf Draft Nasal Spray 211635 11/2020
Diazoxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diazoxide_oral_suspension_17453_RC02-14.pdf Draft Oral Suspension 017453 04/2014
Dichlorphenamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dichlorphenamide_Oral_tablets_NDA_011366_RC_Oct_2018.pdf Draft Oral Tablet 011366 11/2018
Diclofenac https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_oral capsule_204592_RC03-15.pdf Draft Oral Capsule 204592 03/2015
Diclofenac Epolamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021234.pdf Draft Topical Patch 021234 11/2019
Diclofenac Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Potassium_cap_22202_RC4-11.pdf Draft Oral Capsule 022202 04/2011
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac sodium_topical solution_NDA 204623_RC05-17.pdf Draft Topical Solution 204623 07/2017
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_ Sodium_sol_top_20947_RC04-11.pdf Draft Topical Solution 020947 06/2011
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac Sodium_draft_Topical gel_RLD 22122_RC07-18.pdf Draft Topical Gel 022122 07/2018
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac Sodium Topical Gel NDA 021005 RV Feb 2019.pdf Draft Topical Gel 021005 02/2019
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Sodium_DRtab_19201_74376_RC10-09.pdf Draft Oral Tablet, Delayed Release 019201 10/2009
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Sodium_ERtab_20254_RC10-09.pdf Draft Oral Tablet, Extended Release 020254 10/2009
Diclofenac Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac sodium_ophthalmic solution_NDA 020037_RV08-17.pdf Draft Ophthalmic Solution, Drops 020037 10/2017
Diclofenac Sodium; Misoprostol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diclofenac_Sodium;_Misoprostol_ DRtab_20607_ RC2-02.pdf Draft Oral Tablet, Delayed Release 020607 12/2009
Dicloxacillin Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dicloxacillin_cap_62286_RC6-05.pdf Final Oral Capsule 061454 05/2008
Didanosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Didanosine_tab_for_susp_77275_RV06-13.pdf Draft Oral Tablet, For Suspension 077275 06/2013
Didanosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021183.pdf Draft Oral Capsule, Delayed Release Pellets 021183 11/2019
Dienogest;Estradiol Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dienogest;_Estradiol_Valerate_tab_22252_RC12-10.pdf Draft Oral Tablet 022252 12/2010
Diethylpropion Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diethylpropion_ERtab_ 12546_RC12-09.pdf Draft Oral Tablet, Extended Release 012546 12/2009
Diflorasone Diacetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflorasone_Ointment_075331_RC07-14.pdf Draft Topical Ointment 019260 07/2014
Diflorasone Diacetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflorasone diacetate_topical cream_RLD 075508_RC01-16.pdf Draft Topical Cream 075508 01/2016
Diflorasone Diacetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflorasone diacetate_topical cream_RLD 076263_RC01-16.pdf Draft Topical Cream 076263 01/2016
Diflunisal https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diflunisal_ oral tablet_ RLD18445_Final 08-17.pdf Final Oral Tablet 018445 08/2017
Difluprednate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Difluprednate_ophthalmic emulsion_RLD 022212_RV02-17.pdf Draft Ophthalmic Emulsion 022212 02/2017
Digoxin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Digoxin_oral tablet_NDA 020405_RV08-17.pdf Draft Oral Tablet 020405 08/2017
Dihydroergotamine Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020148.pdf Draft Nasal Spray, Metered 020148 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021392.pdf Draft Oral Tablet, Extended Release 021392 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020401.pdf Draft Oral Capsule, Extended Release 020401 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020092.pdf Draft Oral Capsule, Extended Release 020092 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020062.pdf Draft Oral Capsule, Extended Release 020062 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019471.pdf Draft Oral Capsule, Extended Release 019471 06/2020
Diltiazem Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018602.pdf Draft Oral Tablet 018602 03/2020
Dimethyl Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dimethyl fumarate_DRcap_204063_RC07-14.pdf Draft Oral Capsule, Delayed Release 204063 07/2014
Dinoprostone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dinoprostone_Supp_Vag_017810_RC06-12.pdf Draft Vaginal Suppository 017810 06/2012
Dinoprostone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dinoprostone_insert_vag_ER_20411_RC11-11.pdf Draft Vaginal Insert, Extended Release 020411 11/2011
Dinoprostone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dinoprostone_gel_endocx_19617_RC9-11.pdf Draft Endocervical Gel 019617 09/2011
Diphenhydramine Citrate; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021394.pdf Draft Oral Tablet 021394 09/2019
Diphenhydramine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diphenhydramine HCl_ oral capsule_ ANDA 80738_Final 08-17c.pdf Final Oral Capsule 080738 08/2017
Diphenhydramine Hydrochloride; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diphenhydramine_HCl_Ibuprofen_caps_21393_RC06-12_OTC.pdf Draft Oral Capsule 021393 06/2012
Diphenhydramine Hydrochloride; Naproxen Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Diphenhydramine HCL_Naproxen Sodium_Oral tab_205352_RC03-15.pdf Draft Oral Tablet 205352 03/2015
Dipyridamole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dipyridamole_ oral tablet_ RLD 12836_Final 08-17.pdf Final Oral Tablet 012836 08/2017
Diroximel Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211855.pdf Draft Oral Capsule, Delayed Release 211855 08/2020
Disopyramide Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017447.pdf Draft Oral Capsule 017447 11/2019
Disopyramide Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Disopyramide_Phosphate_ERcap_18655_RC10-08.pdf Draft Oral Capsule, Extended Release 018655 10/2008
Disulfiram https://www.accessdata.fda.gov/drugsatfda_docs/psg/Disulfiram_ oral tablet_ RLD 007883_Final 08-17.pdf Final Oral Tablet 007883 08/2017
Divalproex Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Divalproex sodium__oral DR tablet_RLD 018723_RV12-16.pdf Draft Oral Tablet, Delayed Release 018723 12/2016
Divalproex Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Divalproex sodium_oral DR pellets capsule_RLD 019680_RV12-16.pdf Draft Oral Capsule, Delayed Release Pellets 019680 12/2016
Divalproex Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Divalproex sodium__oral ER tablet_RLD 21168_RV12-16.pdf Draft Oral Tablet, Extended Release 021168 12/2016
Docosanol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Docosanol_topical cream_NDA 020941_RC08-17.pdf Draft Topical Cream 020941 10/2017
Dofetilide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dofetilide_cap_20931_RC10-05.pdf Final Oral Capsule 020931 05/2008
Dolasetron Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dolasetron_Mesylate_tab_20623_RC5-10.pdf Draft Oral Tablet 020623 05/2010
Dolutegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204790.pdf Draft Oral Tablet 204790 08/2020
Dolutegravir Sodium; Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211994.pdf Draft Oral Tablet 211994 06/2020
Dolutegravir Sodium; Rilpivirine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210192.pdf Draft Oral Tablet 210192 08/2020
Donepezil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil HCl_Oral Tablet_RLD 22568_Final 08-17.pdf Final Oral Tablet 022568 08/2017
Donepezil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil_HCl_ODtab_21720_RC5-06.pdf Draft Oral Tablet, Orally Disintegrating 021720 04/2010
Donepezil Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil_HCl_tab_20690_RC10-05.pdf Draft Oral Tablet 020690 04/2010
Donepezil Hydrochloride;Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Donepezil Hydrochloride; Memantine Hydrochloride_draft_Oral cap ER_RLD 206439_RC07-18.pdf Draft Oral Capsule 206439 07/2018
Doravirine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210806.pdf Draft Oral Tablet 210806 03/2020
Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210807.pdf Draft Oral Tablet 210807 03/2020
Dorzolamide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/DORZOLAMIDE HYDROCHLORIDE_ophthalmic solution_NDA 020408_RV07-17.pdf Draft Ophthalmic Solution, Drops 020408 07/2017
Doxazosin Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxazosin mesylate_Oral tablet_RLD 19668_Final 08-17.pdf Final Oral Tablet 019668 08/2017
Doxazosin Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxazosin_Mesylate_ERtab_21269_RC9-06.pdf Final Oral Tablet, Extended Release 021269 05/2008
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020126.pdf Draft Topical Cream 020126 11/2019
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxepin_HCl_Oral Capsule_RLD 16798_Final 08-17.pdf Final Oral Capsule 016798 08/2017
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxepin_HCl_tabs_22036_RC09-10.pdf Draft Oral Tablet 022036 09/2010
Doxepin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxepin_HCl_Oral Capsule_70791_RV03-15.pdf Draft Oral Capsule 016798 03/2015
Doxercalciferol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxercalciferol_oral capsule_RLD 20862_Final 08-17.pdf Final Oral Capsule 020862 08/2017
Doxorubicin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxorubicin Hydrochloride_draft_Injection injec lipo_RLD 50718_RC09-18.pdf Draft Injection Injectable, Liposomal 050718 09/2018
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_Capsule_050641_RC07-14.pdf Draft Oral Capsule 050641 07/2014
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_Capsule_065055_RC07-14.pdf Draft Oral Capsule 065055 07/2014
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_ DRcap_50805_RC2-08.pdf Draft Oral Capsule 050805 02/2008
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_tab_65070_RC10-05.pdf Draft Oral Tablet 065070 01/2008
Doxycycline https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_susp_50006_RC8-08.pdf Draft Oral Suspension 050006 08/2008
Doxycycline calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline Calcium Oral Suspension NDA 050480 RC Feb 2019.pdf Draft Oral Suspension Suspension 050480 02/2019
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209844.pdf Draft Oral Tablet 209844 11/2019
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral capsule_RLD 208253_RC12-16.pdf Draft Oral Capsule 208253 12/2016
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hydate_oral tablet_205931_RC06-15.pdf Draft Oral Tablet 205931 06/2015
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline_Hyclate_cap_50007_RC7-08.pdf Draft Oral Capsule 050007 07/2008
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral DR tablet_NDA 050795_RV03-18.pdf Draft Oral Tablet, Delayed Release 050795 03/2018
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxycycline hyclate_oral tablet_NDA 050783_RC11-17.pdf Draft Oral Tablet 050783 02/2018
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050533.pdf Draft Oral Tablet 050533 03/2021
Doxylamine Succinate; Pyridoxine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxylamine succinate_Pyridoxine HCl_DRtab_21876_RC07-14.pdf Draft Oral Tablet, Delayed Release 021876 07/2014
Doxylamine succinate; Pyridoxine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Doxylamine succinate and pyridoxine hydrochloride oral ER tablet NDA 209661 RC Feb 2019.pdf Draft Oral Capsule, Extended Release 209661 02/2019
Dronabinol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dronabinol_cap_18651_RV02-14.pdf Draft Oral Capsule 018651 02/2014
Dronedarone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dronedarone_Hydrochloride_Tablets_022425_RV07-14.pdf Draft Oral Tablet 022425 07/2014
Drospirenone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211367.pdf Draft Oral Tablet 211367 08/2020
Drospirenone; Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone_Estradiol_oral tablet_RLD 021355_RV01-16.pdf Draft Oral Tablet 021355 01/2016
Drospirenone; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone_EE_tabs_21676_RV11-13.pdf Draft Oral Tablet 021676 11/2013
Drospirenone; Ethinyl Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone;_Estradiol_tab(Yazmin)_21098_RC3-09.pdf Draft Oral Tablet 021098 03/2009
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Drospirenone_EE_Levomefolate_tab_22532_22564_RC03-12.pdf Draft Oral Tablet 022532 022574 03/2012
Droxidopa https://www.accessdata.fda.gov/drugsatfda_docs/psg/Droxidopa_Oral capsule_203202_RC06-15.pdf Draft Oral Capsule 203202 06/2015
Duloxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212516.pdf Draft Oral Capsule, Delayed Release 212516 03/2020
Duloxetine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021427.pdf Draft Oral Capsule, Delayed Release Pellets 021427 09/2019
Dutasteride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dutasteride_cap_21319_RC7-05.pdf Final Oral Capsule 021319 05/2008
Dutasteride;Tamsulosin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Dutasteride_tamsulosin_HCl_cap_22460_RV02-14.pdf Draft Oral Capsule 022460 02/2014
Duvelisib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211155.pdf Draft Oral Capsule 211155 09/2019

Newly Added Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202408.pdf Draft Ophthalmic Ointment 202408 08/2021
Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/2021
Amisulpride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209510.pdf Draft Intravenous Solution 209510 08/2021
Avapritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212608.pdf Draft Oral Tablet 212608 08/2021
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008915.pdf Draft Oral Tablet 008915 08/2021
Cefiderocol Sulfate Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209445.pdf Draft Intravenous Powder 209445 08/2021
Copper Dotatate Cu-64 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213227.pdf Draft Intravenous Solution 213227 08/2021
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214278.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021166.pdf Draft Transdermal Gel, Metered 021166 08/2021
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204017.pdf Draft Transdermal System 204017 08/2021
Fostemsavir Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212950.pdf Draft Oral Tablet, Extended Release 212950 08/2021
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017814.pdf Draft Rectal Suppository 017814 08/2021
Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020393.pdf Draft Nasal Spray, Metered 020393 020394 08/2021
Lasmiditan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211280.pdf Draft Oral Tablet 211280 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021343.pdf Draft Subcutaneous Powder 021343 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208219.pdf Draft Ophthalmic Gel 208219 08/2021
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/2021
Osilodrostat Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212801.pdf Draft Oral Tablet 212801 08/2021
Ozanimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209899.pdf Draft Oral Capsule 209899 08/2021
Paliperidone Palmitate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207946.pdf Draft Intramuscular Suspension, Extended Release 207946 08/2021
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213051.pdf Draft Oral Tablet 213051 08/2021
Sufentanil Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209128.pdf Draft Sublingual Tablet 209128 08/2021
Tazemetostat Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211723.pdf 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 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf Draft Oral Capsule 021055 08/2021
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021324.pdf Draft Oral Capsule, Delayed Release 021324 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022291.pdf Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207027.pdf Draft Oral For Suspension 207027 08/2021
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205109.pdf Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021135.pdf Draft Intravenous Injectable 021135 09/2021
Letrozole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020726.pdf Draft Oral Tablet 020726 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019732.pdf Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020517.pdf Draft Injection Injectable 020517 020708 08/2021
Liothyronine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010379.pdf Draft Oral Tablet 010379 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf Draft Ophthalmic Suspension/Drops 020583 08/2021
Nystatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060578.pdf Draft Topical Powder 065203 08/2021
Orlistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020766.pdf Draft Oral Capsule 020766 021887 08/2021
Paclitaxel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021660.pdf Draft IV Infusion For Suspension 021660 08/2021
Podofilox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020529.pdf Draft Topical Gel 020529 08/2021
Sodium Zirconium Cyclosilicate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207078.pdf Draft Oral For Suspension 207078 08/2021
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.05P.pdf Draft Topical Cream 0.05% 021184 08/2021

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