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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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

133 record(s) found for 'E'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Econazole Nitrate Nitrate Topical Cream NDA 018751 RV Feb 2019.pdf Draft Topical Cream 018751 02/2019
Edaravone Draft Intravenous Solution 209176 03/2020
Edoxaban Tosylate Draft Oral Tablet 206316 03/2020
Efavirenz Final Oral Capsule 020972 05/2008
Efavirenz Final Oral Tablet 021360 05/2008
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate Emtricitabine_Tenofovir_Disoproxil_Fumarate_tab_21937_RC10-08.pdf Draft Oral Tablet 021937 10/2008
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate Draft Oral Tablet 210649 06/2020
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate Lamivudine Tenoforvir Dsisoproxile Funarate Tablets NDA208255 PSG Page RC May 2019.pdf Draft Oral Tablet 208255 05/2019
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate Disoproxil Fumarate Oral Tablet NDA 022142 page RC May 2019.pdf Draft Oral Tablet 022142 05/2019
Efinaconazole solution_RLD 203567_RC09-18.pdf Draft Topical Solution 203567 09/2018
Elagolix Sodium Draft Oral Tablet 210450 03/2020
Elbasvir; Grazoprevir; Grazoprevir_ Oral Tablet_ RLD 208261_ RC09-16.pdf Draft Oral Tablet 208261 10/2016
Eletriptan Hydrobromide Final Oral Tablet 021016 10/2011
Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor Draft Oral Tablet, Tablet 212273 03/2021
Eliglustat Tartrate tartrate_capsule_205494_RC06-15.pdf Draft Oral Capsule 205494 06/2015
Eltrombopag Olamine Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine Draft Oral For Suspension 207027 08/2021
Eluxadoline tab_RLD 206940_RC04-16.pdf Draft Oral Tablet 206940 04/2016
Elvitegravir tablet_RLD203093_RC01-16.pdf Draft Oral Tablet 203093 01/2016
Empagliflozin tablet_204629_RC06-15.pdf Draft Oral Tablet 204629 06/2015
Empagliflozin; Linagliptin; Linagliptin_oral tablet_RLD 206073_RC04-16.pdf Draft Oral Tablet 206073 04/2016
Empagliflozin; Linagliptin; Metformin Hydrochloride Draft Oral Tablet, Extended Release 212614 08/2020
Empagliflozin; Metformin Hydrochloride; Metformin HCl_oral ER tablet_NDA 208658_RC08-17.pdf Draft Oral Tablet, Extended Release 208658 10/2017
Empagliflozin; Metformin Hydrochloride; Metformin hydrochloride_oral tab_RLD 206111_RC06-16.pdf Draft Oral Tablet 206111 06/2016
Emtricitabine Final Oral Capsule 021500 08/2010
Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate; Rilpivirine HCL; 208351_RV08-17.pdf Draft Oral Tablet 208351 10/2017
Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate disoproxil fumaratetab202123RC03-15.pdf Draft Oral Tablet 202123 03/2015
Emtricitabine; Tenofovir Alafenamide Fumarate Draft Oral Tablet 208215 10/2017
Emtricitabine; Tenofovir Disoproxil Fumarate; Tenofovir disoproxil fumarate_oral tablet_RLD 21752_RV03-17.pdf Draft Oral Tablet 021752 05/2017
Enalapril Maleate Draft Oral Tablet 018998 08/2008
Enasidenib mesylate mesylate_draft_Oral tab_RLD 209606_RC09-18.pdf Draft Oral Tablet 209606 09/2018
Encorafenib Draft Oral Capsule 210496 11/2019
Enoxaparin Sodium Draft Subcutaneous Injection 020164 10/2011
Entacapone Draft Oral Tablet 020796 06/2013
Entecavir Final Oral Tablet 021797 05/2008
Entrectinib Draft Oral Capsule 212725 03/2021
Enzalutamide Capsule_203415_RC06-15.pdf Draft Oral Capsule 203415 06/2015
Epinephrine and subcutaneous injectable_NDA 020800_RC08-17.pdf Draft Intramuscular/Subcutaneous Injectable 020800 10/2017
Epinephrine injection_RLD 19430_RC12-16.pdf Draft Intramuscular, Subcutaneous Injectable 019430 12/2016
Epinephrine subcutaneous solution_RLD 207534_RC07-18.pdf Draft Intramuscular, Subcutaneous Solution 207534 07/2018
Epinephrine Draft Inhalation Aerosol, Metered 205920 11/2020
Eplerenone Final Oral Tablet 021437 05/2008
Eprosartan Mesylate Mesylate_Oral Tablet_RLD 020738_Final 08-17.pdf Final Oral Tablet 020738 08/2017
Eprosartan Mesylate; Hydrochlorothiazide;_HCTZ_tab_21268_RC2-08.pdf Draft Oral Tablet 021268 02/2008
Eravacycline Dihydrochloride DIHYDROCHLORIDE POWDER INTRAVENOUS NDA 211109 PSG Page RC May 2019.pdf Draft Intravenous Powder 211109 05/2019
Erdafitinib Draft Oral Tablet 212018 08/2020
Ergocalciferol Draft Oral Capsule 003444 07/2014
Erlotinib Hydrochloride Final Oral Tablet 021743 05/2008
Ertugliflozin tablet_NDA 209803_RC Oct 2018.pdf Draft Oral Tablet 209803 11/2018
Ertugliflozin; Metformin hydrochloride; Metformin Hydrochloride_Oral tablet_NDA 209806_RC Oct 2018.pdf Draft Oral Tablet 209806 11/2018
Ertugliflozin; Sitagliptin phosphate; Sitagliptin Phosphateoral_Oral tablet_NDA 209805_RC Oct 2018.pdf Draft Oral Tablet 209805 11/2018
Erythromycin gel_NDA 050617_RC08-17.pdf Draft Topical Gel 050617 10/2017
Erythromycin Draft Oral Tablet, Delayed Release 062298 04/2014
Erythromycin ointment_RLD 062447_RV09-16.pdf Draft Ophthalmic Ointment 062447 10/2016
Erythromycin 64187_RC2-10.pdf Draft Topical Solution 064187 02/2010
Erythromycin Draft Topical Swab 064126 02/2010
Erythromycin tablet_RLD 061621_RC01-16.pdf Draft Oral Tablet 061621 01/2016
Erythromycin Ethylsuccinate Draft Oral Tablet 061904 061905 11/2020
Erythromycin Ethylsuccinate Draft Oral Granule 050207 11/2020
Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl Draft Oral Granule 050529 11/2020
Escitalopram Oxalate Draft Oral Capsule 077660 09/2008
Escitalopram Oxalate Final Oral Tablet 021323 05/2008
Esketamine Hydrochloride Draft Nasal Spray 211243 08/2020
Eslicarbazepine Acetate acetate_oral tablet_022416_RC09-15.pdf Draft Oral Tablet 022416 09/2015
Esomeprazole Magnesium magnesium_oral DR tablet_NDA 207920_RV08-17.pdf Draft Oral Tablet, Delayed Release 207920 10/2017
Esomeprazole Magnesium magnesium_oral DR suspension_NDA 021957 and 022101_RV11-17.pdf Draft Oral Powder For Suspension, Delayed Release 021957 022101 02/2018
Esomeprazole Magnesium magnesium_oral DR capsule pellets_NDA 021153_RV11-17.pdf Draft Oral Capsule, Delayed Release Pellets 021153 02/2018
Esomeprazole Magnesium Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Esomeprazole Magnesium Draft Oral Capsule, Delayed Release 204655 08/2020
Esomeprazole Magnesium; Naproxen;_Naproxen_DRtab_22511_RC03-11.pdf Draft Oral Tablets, Delayed Release 022511 03/2011
Esomeprazole Strontium Strontium_draft_Oral cap DR_RLD 202342_RC07-18.pdf Draft Oral Capsule, Delayed Release 202342 07/2018
Estradiol Draft Oral Tablet 081295 084499 084500 12/2010
Estradiol Draft Transdermal Film, Extended Release 203752 11/2019
Estradiol Draft Transdermal Film, Extended Release 019081 11/2019
Estradiol Draft Transdermal Film, Extended Release 020375 021674 11/2019
Estradiol Draft Transdermal Film, Extended Release 020538 11/2019
Estradiol Draft Vaginal Cream 086069 09/2014
Estradiol 08-09.pdf Draft Vaginal Tablet 020908 03/2011
Estradiol Draft Transdermal Gel 022038 11/2019
Estradiol Draft Transdermal Gel, Metered 021166 08/2021
Estradiol Draft Vaginal Insert, Extended Release 020472 06/2020
Estradiol; Levonorgestrel Draft Transdermal Film, Extended Release 021258 11/2019
Estradiol; Norethindrone Acetate Draft Transdermal Film, Extended Release 020870 11/2019
Estradiol; Norethindrone Acetate;_Norethindrone_Acetate_(Activella)_tab_20907_RC3-09.pdf Draft Oral Tablet 020907 03/2009
Estramustine Phosphate Sodium Draft Oral Capsule 018045 04/2013
Estrogen; Esterified estrogen_84948_RC09-12.pdf Draft Oral Tablet 084948 084949 084950 084951 09/2012
Estrogens, Conjugated Draft Oral Tablet 004782 12/2014
Estrogens; Conjugated Synthetic A Draft Oral Tablet 020992 04/2010
Eszopiclone Draft Oral Tablet 021476 01/2008
Ethacrynic Acid Draft Oral Tablet 016092 12/2010
Ethambutol Hydrochloride HCl_oral tablet_RLD 016320_Final 08-17.pdf Final Oral Tablet 016320 08/2017
Ethinyl Estradiol; Ethynodiol Diacetate;_Ethynodiol_Diacetate_(Zovia)_tab_72723_72721_RC10-09.pdf Draft Oral Tablet 072721 072723 12/2009
Ethinyl Estradiol; Etonogestrel Draft Vaginal Ring 021187 04/2013
Ethinyl Estradiol; Levonorgestrel Draft Oral Tablet 021544 021840 022262 204061 12/2014
Ethinyl Estradiol; Levonorgestrel;_Levonorgestrel_(Trivora)_tab_74538_RC11-09.pdf Draft Oral Tablet 019190 019192 11/2009
Ethinyl Estradiol; Levonorgestrel;_Levonorgestrel_tab_21864_RC4-09.pdf Draft Oral Tablet 021864 04/2009
Ethinyl Estradiol; Levonorgestrel;_Levonorgestrel_(Nordette)_tab_18782_RC3-09.pdf Draft Oral Tablet 018782 03/2009
Ethinyl Estradiol; Levonorgestrel;_Levonorgestrel_tab_76625_RC3-09.pdf Draft Oral Tablet 020683 03/2009
Ethinyl Estradiol; Levonorgestrel;_Levonorgestrel_(Levite)_20860_RC10-08.pdf Draft Oral Tablet 020860 10/2008
Ethinyl Estradiol; Levonorgestrel Draft Transdermal System 204017 08/2021
Ethinyl Estradiol; Levonorgestrel Draft Oral Tablet 208612 03/2021
Ethinyl Estradiol; Levonorgestrel Draft Oral Tablet 209405 03/2021
Ethinyl Estradiol; Norelgestromin Draft Transdermal Film, Extended Release 200910 021180 11/2019
Ethinyl Estradiol; Norethindrone Draft Oral Tablet, Chewable 203667 07/2014
Ethinyl Estradiol; Norethindrone Draft Oral Tablet, Chewable 022573 03/2012
Ethinyl Estradiol; Norethindrone estradiol and Norethindrone_oral tablets_203006 and 200897 _RV09-15.pdf Draft Oral Tablet 200897 203006 09/2015
Ethinyl Estradiol; Norethindrone;_Norethindrone_(Trinorinyl)_tab_18977_RC11-09.pdf Draft Oral Tablet 018977 11/2009
Ethinyl Estradiol; Norethindrone;_Norethindrone__Femcon__chewtab_21490_RC03-09.pdf Draft Oral Tablet, Chewable 021490 07/2010
Ethinyl Estradiol; Norethindrone Draft Oral Tablet 017735 017919 018985 12/2010
Ethinyl Estradiol; Norethindrone Acetate Draft Oral Tablet 022501 06/2011
Ethinyl Estradiol; Norethindrone Acetate;NorethindroneAcetate(Loestrin)tab17355_17875_17354_17876_21871RC10-09.pdf Draft Oral Tablet 017354 017355 021871 10/2009
Ethinyl Estradiol; Norethindrone Acetate;_Norethindrone_Acetate_(Estrostep)_tab_20130_RC7-08.pdf Draft Oral Tablet 020130 07/2008
Ethinyl Estradiol; Norethindrone Acetate;_Norethindrone_Acetate_(Femhrt)_21065_tab_RC7-08.pdf Draft Oral Tablet 021065 07/2008
Ethinyl Estradiol; Norethindrone Acetate estradiol_Norethindrone acetate_oral tablet_RLD204654_RC01-16.pdf Draft Oral Tablet, Chewable 204654 01/2016
Ethinyl estradiol; Norethindrone acetate estradiol; Norethindrone acetate_draft_Oral cap_RLD 204426_RC07-18.pdf Draft Oral Capsule 204426 07/2018
Ethinyl Estradiol; Norgestimate;_Norgestimate_tab _19653_19697_21241_RC12-09.pdf Draft Oral Tablet 019653 019697 021241 12/2009
Ethinyl Estradiol; Norgestrel;_Norgestrel_(Ogestrel)_tab_75406_75288_RC10-09.pdf Draft Oral Tablet 075288 075406 10/2009
Ethiodized Oil Oil_intralymphatic intrauterine oil_RLD 009190_RC12-16.pdf Draft Intralymphatic, Intrauterine, Selective Hepatic Intra-arterial Injectable 009190 12/2016
Ethionamide Draft Oral Tablet 013026 04/2013
Ethosuximide cap_RLD 012380_RC07-18.pdf Draft Oral Capsule 012380 07/2018
Etidronate Disodium Final Oral Tablet 017831 05/2008
Etodolac Draft Oral Capsule 018922 11/2013
Etodolac Draft Oral Tablet 018922 11/2013
Etodolac Draft Oral Tablet, Extended Release 020584 07/2010
Etoposide Draft Oral Capsule 075635 08/2010
Etravirine Draft Oral Tablet 022187 09/2012
Everolimus tablet for suspension_NDA 203985_RC08-17.pdf Draft Oral Tablet For Suspension 203985 10/2017
Everolimus tab_RLD 22334_RC11-18.pdf Draft Oral Tablet 022334 11/2018
Everolimus Draft Oral Tablet 021560 06/2020
Exemestane Final Oral Tablet 020753 05/2008
Ezetimibe Draft Oral Tablet 021445 10/2008
Ezetimibe; Simvastatin;_Simvastatin_tab_21687_RC9-08.pdf Draft Oral Tablet 021687 09/2008
Ezogabine Draft Oral Tablet 022345 04/2013

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English