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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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


43 record(s) found for 'H'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Halcinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halcinonide_topical cream_RLD 017556_RC12-16.pdf Draft Topical Cream 017556 12/2016
Halcinonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halcinonide topical ointment NDA 017824 PSG Page RC May 2019.pdf Draft Topical Ointment 017824 05/2019
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halobetasol_topical lotion_RLD 208183_RC 09-16.pdf Draft Topical Lotion 208183 10/2016
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halobetasol propionate_topical cream_NDA 19967_RC04-16.pdf Draft Topical Cream 019967 04/2016
Halobetasol Propionate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Halobetasol propionate_topical ointment_NDA 19968_RC04-16.pdf Draft Topical Ointment 019968 04/2016
Haloperidol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Haloperidol Oral Tablets NDA 015921 RV Feb 2019.pdf Draft Oral Tablet 015921 02/2019
Homatropine Methylbromide; Hydrocodone Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Homatropine_Methylbromide;_Hydrocodone_Bitartrate_tabs_88508_RC12-09.pdf Draft Oral Tablet 005213 12/2009
Hydralazine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydralazine_tab_89098_89097_88467_88468_RC7-08.pdf Draft Oral Tablet 008303 07/2008
Hydralazine Hydrochloride; Isosorbide Dinitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydralazine;_Isosorbide_tab_20727_RC12-09.pdf Draft Oral Tablet 020727 12/2009
Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_tab_40735_RC5-10.pdf Draft Oral Tablet 011835 05/2010
Hydrochlorothiazide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_cap_20504_RC11-05.pdf Final Oral Capsule 020504 05/2008
Hydrochlorothiazide; Lisinopril https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_lisinopril_tab_19888_RV12-12.pdf Draft Oral Tablet 019888 019778 12/2012
Hydrochlorothiazide; Losartan Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide; Losartan potassium_oral tablet_RLD 20387_Final 08-17.pdf Final Oral Tablet 020387 08/2017
Hydrochlorothiazide; Metoprolol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metoprolol_Tartrate;_HCTZ_tab_18303_RC08-10.pdf Draft Oral Tablet 018303 08/2010
Hydrochlorothiazide; Moexipril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_Moexipril_HCl_Tablets_020729_RV07-14.pdf Draft Oral Tablet 020729 07/2014
Hydrochlorothiazide; Olmesartan Medoxomil https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Olmesartan_tab_21532_RC7-06.pdf Final Oral Tablet 021532 05/2008
Hydrochlorothiazide; Quinapril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide;_Quinapril_HCl_tabs_20125_RC07-10.pdf Draft Oral Tablet 020125 07/2010
Hydrochlorothiazide; Spironolactone https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Spironolactone_tabs_12616_RC12-09.pdf Draft Oral Tablet 012616 12/2009
Hydrochlorothiazide; Telmisartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Telmisartan_tab_21162_RC7-08.pdf Draft Oral Tablet 021162 07/2008
Hydrochlorothiazide; Triamterene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide_triamterene_tab_19129_RC06-13.pdf Draft Oral Tablet 019129 06/2013
Hydrochlorothiazide; Triamterene https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide triamterene_oral capsule_RLD 016042, 073191_Final 08-17.pdf Final Oral Capsule 016042 073191 08/2017
Hydrochlorothiazide; Valsartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrochlorothiazide; Valsartan_Oral Tablet_RLD 20818_Final 08-17.pdf Final Oral Tablet 020818 08/2017
Hydrochlorothiazide;Irbesartan https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Irbesartan_tab_20758_RC6-06.pdf Draft Oral Tablet 020758 03/2012
Hydrochlorothiazide;Metoprolol Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/HCTZ_Metoprolol_succinate_ERtab_21956_RC02-14.pdf Draft Oral Tablet, Extended Release 021956 04/2014
Hydrocodone Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocodone bitartrate_oral ER cap_RLD 202880_RC09-16.pdf Draft Oral Capsule, Extended Release 202880 10/2016
Hydrocodone Bitartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocodone bitartrate_oral ER tablet_NDA 206627_RV07-18.pdf Draft Oral Tablet, Extended Release 206627 07/2018
Hydrocodone Bitartrate; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/HYDROCODONE BITARTRATE; IBUPROFEN_oral tablet_RLD 020716_Final 08-17.pdf Final Oral Tablet 020716 08/2017
Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone_topical cream_ANDA 089414_RC03-17.pdf Draft Topical Cream 089414 05/2017
Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone_topical solution_RLD 81271_RC06-16.pdf Draft Topical Solution 081271 06/2016
Hydrocortisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone_ oral tablet_ RLD 008697_Final 08-17.pdf Final Oral Tablet 008697 08/2017
Hydrocortisone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017351.pdf Draft Rectal Aerosol, Metered 017351 11/2020
Hydrocortisone Butyrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone butyrate_topical lotion_RLD 022076_RC03-17.pdf Draft Topical Lotion 022076 05/2017
Hydrocortisone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone valerate_topical ointment_RLD 070543_RC09-16.pdf Draft Topical Ointment 018726 10/2016
Hydrocortisone Valerate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydrocortisone valerate_topical cream_NDA 017950_RC11-17.pdf Draft Topical Cream 017950 02/2018
Hydrogen Peroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209305.pdf Draft Topical Solution 209305 09/2019
Hydromorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydromorphone_ER_Tablets_021217_RC07-14.pdf Draft Oral Tablet, Extended Release 021217 07/2014
Hydromorphone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydromorphone HCl_oral tablet_RLD 19892_Final 08-17.pdf Final Oral Tablet 019892 08/2017
Hydroxychloroquine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_009768.pdf Final Oral Tablet 009768 04/2020
Hydroxyprogesterone Caproate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021945.pdf Draft Intramuscular Solution 021945 09/2019
Hydroxyurea https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydroxyurea_cap_16295_RC8-08.pdf Draft Oral Capsule 016295 08/2008
Hydroxyzine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydroxyzine_HCl_tabs_88617_88618_88619_RC06-10.pdf Draft Oral Tablet 088617 088618 088619 06/2010
Hydroxyzine Pamoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydroxyzine_Pamoate_cap_11459_RC4-09.pdf Final Oral Capsule 011459 10/2011
Hydroxyzine Pamoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Hydroxyzine_Pamoate_susp_11795_RC4-09.pdf Final Oral Suspension 011795 10/2011

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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