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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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

111 record(s) found for 'L'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Labetalol Hydrochloride Draft Oral Tablet 018716 03/2021
Lacosamide tab_RLD 22253_RC06-12.pdf Draft Oral Tablet 022253 06/2012
Lamivudine tab_RLD 21003_RC11-07.pdf Draft Oral Tablet 021003 11/2007
Lamivudine tab_RLD 20564_RC05-08.pdf Final Oral Tablet 020564 05/2008
Lamivudine; Tenofovir Disoproxil Fumarate Disoproxil Fumarate Oral Tablet NDA 022141 PSG page RC May 2019.pdf Draft Oral Tablet 022141 05/2019
Lamivudine; Tenofovir Disoproxil Fumarate Draft Oral Tablet 022344 09/2019
Lamivudine; Tenofovir Disoproxil Fumarate Draft Oral Tablet 211284 08/2020
Lamivudine; Zidovudine; Zidovudine_final_Oral tab_RLD 20857_RC05-08.pdf Final Oral Tablet 020857 05/2008
Lamotrigine tab ER_RLD 22115_RC01-16.pdf Draft Oral Tablet, Extended Release 022115 01/2016
Lamotrigine tab chewable_RLD 20764_RC05-08.pdf Final Oral Tablet, Chewable 020764 05/2008
Lamotrigine Final Oral Tablet 020241 05/2008
Lamotrigine tab disintegrating_RLD 022251_RC09-18.pdf Draft Oral Tablet, Orally Disintegrating 022251 09/2018
Lanreotide Acetate Acetate_draft_Subcutaneous injection_RLD 22074_RC07-14.pdf Draft Subcutaneous Injection 022074 07/2014
Lansoprazole cap DR_RLD 20406_RC07-18.pdf Draft Oral Capsule, Delayed Release 020406 07/2018
Lansoprazole tab delayed-release OD_RLD 21428_RC02-18.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 021428 02/2018
Lanthanum Carbonate carbonate_draft_Oral powder_RLD 204734_RC06-15.pdf Draft Oral Powder 204734 06/2015
Lanthanum Carbonate Carbonate_draft_Oral tabs chewable_RLD 21468_RC05-17.pdf Draft Oral Tablet, Chewable 021468 05/2017
Lapatinib Ditosylate Ditosylate_draft_Oral tab_RLD 22059_RC07-10.pdf Draft Oral Tablet 022059 07/2010
Larotrectinib Sulfate Draft Oral Capsule 210861 08/2020
Lasmiditan Succinate Draft Oral Tablet 211280 08/2021
Latanoprost Draft Ophthalmic Emulsion 206185 06/2020
Latanoprost solution_RLD 20597_RC07-18.pdf Draft Ophthalmic Solution 020597 07/2018
Latanoprost; Netarsudil Dimesylate Draft Ophthalmic Solution/Drops 208259 11/2019
Latanoprostene bunod Bunod_Ophthalmic solution drops_NDA 207795_RC Oct 2018.pdf Draft Ophthalmic Solution, Drops 207795 11/2018
Ledipasvir; Sofosbuvir Draft Oral Pellets 212477 03/2021
Ledipasvir; Sofosbuvir Draft Oral Tablet 205834 05/2021
Lefamulin Acetate Draft Oral Tablet 211672 11/2020
Lefamulin Acetate Draft Intravenous Solution 211673 08/2020
Leflunomide tab_RLD 20905_RC08-07.pdf Draft Oral Tablet 020905 08/2007
Lenalidomide cap_RLD 21880_RC11-13.pdf Draft Oral Capsule 021880 11/2013
Lenvatinib Mesylate mesylate_draft_Oral cap_RLD 206947_RC04-16.pdf Draft Oral Capsule 206947 04/2016
Lesinurad tab_RLD 207988_RC06-16.pdf Draft Oral Tablet 207988 06/2016
Letermovir Draft IV Infusion, Subcutaneous Solution 209940 11/2018
Letermovir tablet_NDA 209939_RC Oct 2018.pdf Draft Oral Tablet 209939 11/2018
Letrozole Draft Oral Tablet 020726 08/2021
Letrozole;Ribociclib Succinate and Ribociclib Succinate Copackaged Oral Tablet NDA 209935 RC Feb 2019.pdf Draft Oral Tablet 209935 02/2019
Leucovorin Calcium Calcium_draft_Oral tab_RLD 18342_RC07-18.pdf Draft Oral Tablet 018342 07/2018
Leuprolide Acetate Acetate_draft_Implantation implant_RLD 21088_RC07-08.pdf Draft Implantation Implant 021088 07/2008
Leuprolide Acetate Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate Draft Subcutaneous Powder 021343 08/2021
Leuprolide Acetate Draft Injection Injectable 020517 020708 08/2021
Leuprolide Acetate; Norethindrone Acetate RC11-17.pdf Draft Intramuscular, Oral Injectable, Tablet 203696 02/2018
Levalbuterol Tartrate Draft Inhalation Aerosol, Metered 021730 03/2020
Levetiracetam Draft Oral Tablet, Extended Release 204417 09/2019
Levetiracetam tab ER_RLD 22285_RC02-10.pdf Draft Oral Tablet, Extended Release 022285 02/2010
Levetiracetam tab_RLD 21035_RC10-11.pdf Final Oral Tablet 021035 10/2011
Levetiracetam Suspension tabs_RLD 207958_RC02-18.pdf Draft Oral Suspension Tablets 207958 02/2018
Levocarnitine tab_RLD 018948_RC09-15.pdf Draft Oral Tablet 018948 09/2015
Levocetirizine Dihydrochloride Dihydrochloride_draft_Oral tab_RLD 22064_RC10-08.pdf Draft Oral Tablet 022064 10/2008
Levocetirizine Dihydrochloride dihydrochloride_draft_Oral tabs_RLD 209089_RC02-18.pdf Draft Oral Tablets 209089 02/2018
Levofloxacin tab_RLD 20634_RC08-10.pdf Draft Oral Tablet 020634 08/2010
Levomilnacipran Hydrochloride Hydrochloride_draft_Oral cap ER_RLD 204168_RC12-16.pdf Draft Oral Capsule, Extended Release 204168 12/2016
Levonorgestrel tab_RLD 21998 21045_RC02-11.pdf Draft Oral Tablet 021045 021998 02/2011
Levonorgestrel Draft Intrauterine Intrauterine Device 021225 01/2020
Levorphanol Tartrate Draft Oral Tablet 008720 11/2020
Levothyroxine Sodium sodium_draft_Oral tab_RLD 021116 021210 021301 021342 021402_RC12-14.pdf Draft Oral Tablet 021116 021210 021301 021342 021402 12/2014
Levothyroxine sodium capsules_NDA 021924_RC Oct 2018.pdf Draft Oral Capsules 021924 11/2018
Lidocaine Draft Topical Patch 207962 11/2019
Lidocaine ointment_RLD 008048_RC12-16.pdf Draft Topical Ointment 008048 12/2016
Lidocaine Draft Topical Patch 020612 11/2019
Lidocaine; Prilocaine; Prilocaine_draft_Topical cream_RLD 019941_RC12-14.pdf Draft Topical Cream 019941 12/2014
Lifitegrast solution drops_NDA 208073_RC Oct 2018.pdf Draft Ophthalmic Drops, Solution 208073 11/2018
Linaclotide Draft Oral Capsules 202811 12/2018
Linagliptin tab_RLD 201280_RC09-12.pdf Draft Oral Tablet 201280 09/2012
Linagliptin; Metformin Hydrochloride; Metformin Hydrochloride_draft_Oral tab ER_RLD 208026_RC05-17.pdf Draft Oral Tablet, Extended Release 208026 05/2017
Linagliptin; Metformin Hydrochloride; Metformin Hydrochloride_draft_Oral tab_RLD 201281_RC07-14.pdf Draft Oral Tablet 201281 07/2014
Linezolid susp_RLD 21132_RC10-11.pdf Final Oral Suspension 021132 10/2011
Linezolid tab_RLD 21130_RC08-10.pdf Draft Oral Tablet 021130 08/2010
Liothyronine Sodium Draft Oral Tablet 010379 08/2021
Liraglutide Draft Subcutaneous Solution 022341 03/2020
Lisdexamfetamine Dimesylate dimesylate PDF - 40KB)_draft_Oral tabs chewable_RLD 208510_RC10-17.pdf Draft Oral Tablets, Chewable 208510 10/2017
Lisdexamfetamine Dimesylate Dimesylate_draft_Oral cap_RLD 21977_RC10-17.pdf Draft Oral Capsule 021977 10/2017
Lisinopril tab_RLD 19777_RC01-08.pdf Draft Oral Tablet 019777 01/2008
Lithium Carbonate Carbonate_draft_Oral tab ER_RLD 76691_RC02-10.pdf Draft Oral Tablet, Extended Release 076691 02/2010
Lithium Carbonate Carbonate_draft_Oral tab ER_RLD 18027_RC02-10.pdf Draft Oral Tablet, Extended Release 018027 02/2010
Lithium Carbonate Carbonate_draft_Oral tab_RLD 18558_RC02-10.pdf Draft Oral Tablet 018558 02/2010
Lithium Carbonate Draft Oral Capsule 017812 11/2019
Lofexidine Hydrochloride Draft Oral Tablet 209229 09/2019
Lomitapide Mesylate Draft Oral Capsule 203858 11/2020
Lomustine cap_RLD 017588_RC07-14.pdf Draft Oral Capsule 017588 07/2014
Loperamide Hydrochloride Hydrochloride_draft_Oral tab chewable_RLD 20448_RC03-15.pdf Draft Oral Tablet, Chewable 020448 03/2015
Loperamide Hydrochloride Hydrochloride_draft_Oral cap_RLD 021855_RC03-15.pdf Draft Oral Capsule 021855 03/2015
Loperamide Hydrochloride Hydrochloride_draft_Oral cap_RLD 17694_RC03-15.pdf Draft Oral Capsule 017694 03/2015
Loperamide Hydrochloride Hydrochloride_draft_Oral susp_RLD 19487_RC03-15.pdf Draft Oral Suspension 019487 03/2015
Loperamide Hydrochloride Draft Oral Tablet 019860 03/2015
Loperamide Hydrochloride; Simethicone Hydrochloride; simethicone_draft_Oral tab_RLD 021140_RC09-15.pdf Draft Oral Tablet 021140 09/2015
Lopinavir; Ritonavir; Ritonavir_draft_Oral cap_RLD 21226_RC09-12.pdf Draft Oral Capsule 021226 09/2012
Lopinavir; Ritonavir; Ritonavir_final_Oral tab_RLD 21906_RC09-12.pdf Final Oral Tablet 021906 09/2012
Loratadine cap_RLD 021952_RC04-13.pdf Draft Oral Capsule 021952 04/2013
Loratadine tab chewable_RLD 21891_RC03-09.pdf Draft Oral Tablet, Chewable 021891 03/2009
Loratadine tab_RLD 19658_RC07-08.pdf Draft Oral Tablet 019658 07/2008
Loratadine tab OD_RLD 20704_RC05-08.pdf Final Oral Tablet, Orally Disintegrating 020704 05/2008
Loratadine; Pseudoephedrine Sulfate; Pseudoephedrine Sulfate_draft_Oral tab ER_RLD 19670_RC08-10.pdf Draft Oral Tablet, Extended Release 019670 08/2010
Loratadine; Pseudoephedrine sulfate Pseudoephedrine Oral Extended Release Tablet NDA 020470 RC Feb 2019.pdf Draft Oral Tablet, Extended Release 020470 02/2019
Lorazepam tab_RLD 17794_RC02-10.pdf Draft Oral Tablet 017794 02/2010
Lorlatinib Draft Oral Tablet 210868 11/2019
Losartan Potassium Potassium_final_Oral tab_RLD 20386_RC05-08.pdf Final Oral Tablet 020386 05/2008
Loteprednol Etabonate Etabonate_draft_Ophthalmic drops susp 0.02_RLD 020803_RC02-18.pdf Draft Ophthalmic Suspension/Drops 020803 02/2018
Loteprednol Etabonate Draft Ophthalmic Suspension/Drops 210565 09/2019
Loteprednol Etabonate Draft Ophthalmic Gel 202872 09/2019
Loteprednol Etabonate Draft Ophthalmic Gel 208219 08/2021
Loteprednol Etabonate Draft Ophthalmic Suspension/Drops 020583 08/2021
Loteprednol Etabonate etabonate_draft_Ophthalmic ointment_RLD 200738_RC07-18.pdf Draft Ophthalmic Ointment 200738 07/2018
Loteprednol Etabonate; Tobramycin Draft Ophthalmic Suspension/Drops 050804 08/2020
Lovastatin Draft Oral Tablet, Extended Release 021316 09/2019
Lubiprostone cap_RLD 21908_RC07-15.pdf Draft Oral Capsule 021908 07/2015
Luliconazole cream_RLD 204153_RC09-18.pdf Draft Topical Cream 204153 09/2018
Lumateperone Tosylate Draft Oral Capsule 209500 05/2021
Lurasidone Hydrochloride Hydrochloride_draft_Oral tab_RLD 200603_RC12-14.pdf Draft Oral Tablet 200603 12/2014
Lusutrombopag Draft Oral Tablet 210923 03/2020
Lutetium Dotatate Lu 177 Draft Intravenous Solution 208700 11/2019

Newly Added Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acyclovir 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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