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Product-Specific Guidances for Generic Drug Development

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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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

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

Total number of currently published PSGs: 2032

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


120 record(s) found for 'L'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Labetalol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018687.pdf Draft Oral Tablet 018716 018687 03/2021
Lacosamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lacosamide_draft_Oral tab_RLD 22253_RC06-12.pdf Draft Oral Tablet 022253 06/2012
Lactitol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211281.pdf Draft Oral For Solution 211281 11/2021
Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamivudine_draft_Oral tab_RLD 21003_RC11-07.pdf Draft Oral Tablet 021003 11/2007
Lamivudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamivudine_final_Oral tab_RLD 20564_RC05-08.pdf Final Oral Tablet 020564 05/2008
Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamivudine-Tenofovir Disoproxil Fumarate Oral Tablet NDA 022141 PSG page RC May 2019.pdf Draft Oral Tablet 022141 05/2019
Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022344.pdf Draft Oral Tablet 022344 09/2019
Lamivudine; Tenofovir Disoproxil Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211284.pdf Draft Oral Tablet 211284 08/2020
Lamivudine; Zidovudine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamivudine; Zidovudine_final_Oral tab_RLD 20857_RC05-08.pdf Final Oral Tablet 020857 05/2008
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamotrigine_tab_20241_RC1-06.pdf Final Oral Tablet 020241 05/2008
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamotrigine_draft_Oral tab ER_RLD 22115_RC01-16.pdf Draft Oral Tablet, Extended Release 022115 01/2016
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020764.pdf Draft Oral Tablet, For Suspension 020764 08/2022
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamotrigine_draft_Oral tab disintegrating_RLD 022251_RC09-18.pdf Draft Oral Tablet, Orally Disintegrating 022251 09/2018
Lanreotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lanreotide Acetate_draft_Subcutaneous injection_RLD 22074_RC07-14.pdf Draft Subcutaneous Injection 022074 07/2014
Lansoprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lansoprazole_draft_Oral cap DR_RLD 20406_RC07-18.pdf Draft Oral Capsule, Delayed Release 020406 07/2018
Lansoprazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021428.pdf Draft Oral Tablet, Delayed Release, Orally Disintegrating 021428 11/2021
Lanthanum Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021468.pdf Draft Oral Tablet, Chewable 021468 08/2022
Lanthanum Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lanthanum carbonate_draft_Oral powder_RLD 204734_RC06-15.pdf Draft Oral Powder 204734 06/2015
Lapatinib Ditosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lapatinib Ditosylate_draft_Oral tab_RLD 22059_RC07-10.pdf Draft Oral Tablet 022059 07/2010
Larotrectinib Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210861.pdf Draft Oral Capsule 210861 08/2020
Lasmiditan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211280.pdf Draft Oral Tablet 211280 08/2021
Latanoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/Latanoprost_draft_Ophthalmic solution_RLD 20597_RC07-18.pdf Draft Ophthalmic Solution 020597 07/2018
Latanoprost https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206185.pdf Draft Ophthalmic Emulsion 206185 06/2020
Latanoprost; Netarsudil Dimesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208259.pdf Draft Ophthalmic Solution/Drops 208259 11/2019
Latanoprostene bunod https://www.accessdata.fda.gov/drugsatfda_docs/psg/Latanoprostene Bunod_Ophthalmic solution drops_NDA 207795_RC Oct 2018.pdf Draft Ophthalmic Solution/Drops 207795 11/2018
Ledipasvir; Sofosbuvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212477.pdf Draft Oral Pellets 212477 03/2021
Ledipasvir; Sofosbuvir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205834.pdf Draft Oral Tablet 205834 05/2021
Lefamulin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211673.pdf Draft Intravenous Solution 211673 08/2020
Lefamulin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211672.pdf Draft Oral Tablet 211672 11/2020
Leflunomide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Leflunomide_draft_Oral tab_RLD 20905_RC08-07.pdf Draft Oral Tablet 020905 08/2007
Lemborexant https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212028.pdf Draft Oral Tablet 212028 11/2021
Lenalidomide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lenalidomide_draft_Oral cap_RLD 21880_RC11-13.pdf Draft Oral Capsule 021880 11/2013
Lenvatinib Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lenvatinib mesylate_draft_Oral cap_RLD 206947_RC04-16.pdf Draft Oral Capsule 206947 04/2016
Lesinurad https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lesinurad_draft_Oral tab_RLD 207988_RC06-16.pdf Draft Oral Tablet 207988 06/2016
Letermovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Letermovir_Oral tablet_NDA 209939_RC Oct 2018.pdf Draft Oral Tablet 209939 11/2018
Letermovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Letermovir_IV_infusion_solution_NDA_209940_RC_Oct_2018.pdf Draft IV Infusion, Subcutaneous Solution 209940 11/2018
Letrozole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020726.pdf Draft Oral Tablet 020726 08/2021
Letrozole;Ribociclib Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Letrozole and Ribociclib Succinate Copackaged Oral Tablet NDA 209935 RC Feb 2019.pdf Draft Oral Tablet 209935 02/2019
Leucovorin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Leucovorin Calcium_draft_Oral tab_RLD 18342_RC07-18.pdf Draft Oral Tablet 018342 07/2018
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021088.pdf Draft Implantation Implant 021088 11/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020517.pdf Draft Injection Injectable 020517 020708 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_021379.pdf Draft Subcutaneous Powder 021379 021488 02/2022
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021731.pdf Draft Subcutaneous Powder 021731 213150 02/2022
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021343.pdf Draft Subcutaneous Powder 021343 08/2021
Leuprolide Acetate; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203696.pdf Draft Intramuscular, Oral Injectable, Tablet 203696 11/2021
Levalbuterol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021730.pdf Draft Inhalation Aerosol, Metered 021730 03/2020
Levetiracetam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levetiracetam_final_Oral tab_RLD 21035_RC10-11.pdf Final Oral Tablet 021035 10/2011
Levetiracetam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204417.pdf Draft Oral Tablet, Extended Release 204417 09/2019
Levetiracetam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levetiracetam_draft_Oral tab ER_RLD 22285_RC02-10.pdf Draft Oral Tablet, Extended Release 022285 02/2010
Levetiracetam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levetiracetam_draft_Oral Suspension tabs_RLD 207958_RC02-18.pdf Draft Oral Suspension Tablet, For Suspension 207958 02/2018
Levocarnitine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levocarnitine_draft_Oral tab_RLD 018948_RC09-15.pdf Draft Oral Tablet 018948 09/2015
Levocetirizine Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levocetirizine Dihydrochloride_draft_Oral tab_RLD 22064_RC10-08.pdf Draft Oral Tablet 022064 10/2008
Levocetirizine Dihydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levocetirizine dihydrochloride_draft_Oral tabs_RLD 209089_RC02-18.pdf Draft Oral Tablet 209089 02/2018
Levofloxacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levofloxacin_draft_Oral tab_RLD 20634_RC08-10.pdf Draft Oral Tablet 020634 08/2010
Levomilnacipran Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levomilnacipran Hydrochloride_draft_Oral cap ER_RLD 204168_RC12-16.pdf Draft Oral Capsule, Extended Release 204168 12/2016
Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levonorgestrel_draft_Oral tab_RLD 21998 21045_RC02-11.pdf Draft Oral Tablet 021045 021998 02/2011
Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021225.pdf Draft Intrauterine Intrauterine Device 021225 01/2020
Levorphanol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008720.pdf Draft Oral Tablet 008720 11/2020
Levothyroxine sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levothyroxine_Sodium capsules_NDA 021924_RC Oct 2018.pdf Draft Oral Capsule 021924 11/2018
Levothyroxine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levothyroxine sodium_draft_Oral tab_RLD 021116 021210 021301 021342 021402_RC12-14.pdf Draft Oral Tablet 021116 021210 021301 021342 021402 12/2014
Lidocaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lidocaine_draft_Topical ointment_RLD 008048_RC12-16.pdf Draft Topical Ointment 008048 12/2016
Lidocaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020612.pdf Draft Topical Patch 020612 11/2019
Lidocaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207962.pdf Draft Topical Patch 207962 11/2019
Lidocaine; Prilocaine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lidocaine; Prilocaine_draft_Topical cream_RLD 019941_RC12-14.pdf Draft Topical Cream 019941 12/2014
Lifitegrast https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lifitegrast_Ophthalmic solution drops_NDA 208073_RC Oct 2018.pdf Draft Ophthalmic Solution/Drops 208073 11/2018
Linaclotide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202811.pdf Draft Oral Capsule 202811 05/2022
Linagliptin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Linagliptin_draft_Oral tab_RLD 201280_RC09-12.pdf Draft Oral Tablet 201280 09/2012
Linagliptin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Linagliptin; Metformin Hydrochloride_draft_Oral tab_RLD 201281_RC07-14.pdf Draft Oral Tablet 201281 07/2014
Linagliptin; Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Linagliptin; Metformin Hydrochloride_draft_Oral tab ER_RLD 208026_RC05-17.pdf Draft Oral Tablet, Extended Release 208026 05/2017
Linezolid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Linezolid_final_Oral susp_RLD 21132_RC10-11.pdf Final Oral Suspension 021132 10/2011
Linezolid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Linezolid_draft_Oral tab_RLD 21130_RC08-10.pdf Draft Oral Tablet 021130 08/2010
Liothyronine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010379.pdf Draft Oral Tablet 010379 02/2022
Liraglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022341.pdf Draft Subcutaneous Solution 022341 03/2020
Lisdexamfetamine Dimesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lisdexamfetamine Dimesylate_draft_Oral cap_RLD 21977_RC10-17.pdf Draft Oral Capsule 021977 10/2017
Lisdexamfetamine Dimesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lisdexamfetamine dimesylate PDF - 40KB)_draft_Oral tabs chewable_RLD 208510_RC10-17.pdf Draft Oral Tablet, Chewable 208510 10/2017
Lisinopril https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lisinopril_draft_Oral tab_RLD 19777_RC01-08.pdf Draft Oral Tablet 019777 01/2008
Lithium Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lithium Carbonate_draft_Oral tab_RLD 18558_RC02-10.pdf Draft Oral Tablet 018558 02/2010
Lithium Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017812.pdf Draft Oral Capsule 017812 11/2019
Lithium Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lithium Carbonate_draft_Oral tab ER_RLD 76691_RC02-10.pdf Draft Oral Tablet, Extended Release 076691 02/2010
Lithium Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lithium Carbonate_draft_Oral tab ER_RLD 18027_RC02-10.pdf Draft Oral Tablet, Extended Release 018027 02/2010
Lofexidine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209229.pdf Draft Oral Tablet 209229 09/2019
Lomitapide Mesylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203858.pdf Draft Oral Capsule 203858 11/2020
Lomustine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lomustine_draft_Oral cap_RLD 017588_RC07-14.pdf Draft Oral Capsule 017588 07/2014
Lonafarnib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213969.pdf Draft Oral Capsule 213969 08/2022
Loperamide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide Hydrochloride_draft_Oral cap_RLD 021855_RC03-15.pdf Draft Oral Capsule 021855 03/2015
Loperamide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide Hydrochloride_draft_Oral cap_RLD 17694_RC03-15.pdf Draft Oral Capsule 017694 03/2015
Loperamide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide Hydrochloride_draft_Oral susp_RLD 19487_RC03-15.pdf Draft Oral Suspension 019487 03/2015
Loperamide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide_HCl_tab_19860_RC03-15.pdf Draft Oral Tablet 019860 03/2015
Loperamide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide Hydrochloride_draft_Oral tab chewable_RLD 20448_RC03-15.pdf Draft Oral Tablet, Chewable 020448 03/2015
Loperamide Hydrochloride; Simethicone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020606.pdf Draft Oral Tablet, Chewable 020606 08/2022
Loperamide Hydrochloride; Simethicone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide Hydrochloride; simethicone_draft_Oral tab_RLD 021140_RC09-15.pdf Draft Oral Tablet 021140 09/2015
Lopinavir; Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lopinavir; Ritonavir_draft_Oral cap_RLD 21226_RC09-12.pdf Draft Oral Capsule 021226 09/2012
Lopinavir; Ritonavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lopinavir; Ritonavir_final_Oral tab_RLD 21906_RC09-12.pdf Final Oral Tablet 021906 09/2012
Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loratadine_draft_Oral tab_RLD 19658_RC07-08.pdf Draft Oral Tablet 019658 07/2008
Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021891.pdf Draft Oral Tablet, Chewable 021891 08/2022
Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020704.pdf Draft Oral Tablet, Orally Disintegrating 020704 11/2021
Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loratadine_draft_Oral cap_RLD 021952_RC04-13.pdf Draft Oral Capsule 021952 04/2013
Loratadine; Pseudoephedrine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loratadine; Pseudoephedrine Sulfate_draft_Oral tab ER_RLD 19670_RC08-10.pdf Draft Oral Tablet, Extended Release 019670 08/2010
Loratadine; Pseudoephedrine sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loratadine Pseudoephedrine Oral Extended Release Tablet NDA 020470 RC Feb 2019.pdf Draft Oral Tablet, Extended Release 020470 02/2019
Lorazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lorazepam_draft_Oral tab_RLD 17794_RC02-10.pdf Draft Oral Tablet 017794 02/2010
Lorazepam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214826.pdf Draft Oral Capsule, Extended Release 214826 05/2022
Lorlatinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210868.pdf Draft Oral Tablet 210868 11/2019
Losartan Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Losartan Potassium_final_Oral tab_RLD 20386_RC05-08.pdf Final Oral Tablet 020386 05/2008
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf Draft Ophthalmic Suspension/Drops 020583 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loteprednol Etabonate_draft_Ophthalmic drops susp 0.02_RLD 020803_RC02-18.pdf Draft Ophthalmic Suspension/Drops 020803 02/2018
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210933.pdf Draft Ophthalmic Suspension/Drops 210933 08/2022
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210565.pdf Draft Ophthalmic Suspension/Drops 210565 09/2019
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208219.pdf Draft Ophthalmic Gel 208219 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202872.pdf Draft Ophthalmic Gel 202872 09/2019
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loteprednol etabonate_draft_Ophthalmic ointment_RLD 200738_RC07-18.pdf Draft Ophthalmic Ointment 200738 07/2018
Loteprednol Etabonate; Tobramycin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050804.pdf Draft Ophthalmic Suspension/Drops 050804 08/2020
Lovastatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021316.pdf Draft Oral Tablet, Extended Release 021316 09/2019
Lubiprostone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lubiprostone_draft_Oral cap_RLD 21908_RC07-15.pdf Draft Oral Capsule 021908 07/2015
Luliconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Luliconazole_draft_Topical cream_RLD 204153_RC09-18.pdf Draft Topical Cream 204153 09/2018
Lumateperone Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209500.pdf Draft Oral Capsule 209500 05/2021
Lurasidone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lurasidone Hydrochloride_draft_Oral tab_RLD 200603_RC12-14.pdf Draft Oral Tablet 200603 12/2014
Lurbinectedin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213702.pdf Draft Intravenous Powder 213702 11/2021
Lusutrombopag https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210923.pdf Draft Oral Tablet 210923 03/2020
Lutetium Dotatate Lu 177 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208700.pdf Draft Intravenous Solution 208700 11/2019

Newly Added Guidances since August 2022

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acetaminophen; Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211733.pdf Draft Oral Tablet 211733 08/2022
Amphetamine; Amphetamine Aspartate/Dextroamphetamine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210526.pdf Draft Oral Tablet, Extended Release 210526 08/2022
Ampicillin/Ampicillin Trihydrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_064082.pdf Draft Oral Capsule 064082 08/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213872.pdf Draft Nasal Spray, Metered 213872 08/2022
Berotralstat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214094.pdf Draft Oral Capsule 214094 08/2022
Cabotegravir Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212887.pdf Draft Oral Tablet 212887 08/2022
Carbamazepine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018281.pdf Draft Oral Tablet, Chewable 018281 08/2022
Caspofungin Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021227.pdf Draft Intravenous Powder 021227 08/2022
Cobicistat; Darunavir; Emtricitabine; Tenofovir Alafenamide Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210455.pdf Draft Oral Tablet 210455 08/2022
Cyclosporine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214965.pdf Draft Ophthalmic Emulsion 214965 08/2022
Cytarabine; Daunorubicin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209401.pdf Draft Intravenous Powder 209401 08/2022
Dasiglucagon Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214231.pdf Draft Subcutaneous Solution 214231 08/2022
Doxycycline Hyclate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050751.pdf Draft Periodontal System, Extended Release 050751 08/2022
Etonogestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021529.pdf Draft Implantation Implant 021529 08/2022
Famotidine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020801.pdf Draft Oral Tablet, Chewable 020801 08/2022
Gallium Ga-68 Gozetotide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212642.pdf Draft Intravenous Solution 212642 212643 08/2022
Ibuprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020601.pdf Draft Oral Tablet, Chewable 020601 08/2022
Ketoprofen https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018754.pdf Draft Oral Capsule 018754 08/2022
Lonafarnib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213969.pdf Draft Oral Capsule 213969 08/2022
Loperamide Hydrochloride; Simethicone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020606.pdf Draft Oral Tablet, Chewable 020606 08/2022
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210933.pdf Draft Ophthalmic Suspension/Drops 210933 08/2022
Mometasone Furoate; Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211746.pdf Draft Nasal Spray, Metered 211746 08/2022
Nifurtimox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213464.pdf Draft Oral Tablet 213464 08/2022
Pafolacianine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214907.pdf Draft Intravenous Solution 214907 08/2022
Relugolix https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214621.pdf Draft Oral Tablet 214621 08/2022
Setmelanotide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213793.pdf Draft Subcutaneous Solution 213793 08/2022
Technetium Tc-99m Sodium Pertechnetate Generator https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202158.pdf Draft Intravenous, Intravesicular, Ophthalmic Solution 202158 08/2022
Vericiguat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214377.pdf Draft Oral Tablet 214377 08/2022
Vibegron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213006.pdf Draft Oral Tablet 213006 08/2022

Newly Revised Guidances since August 2022

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Amoxicillin; Clavulanate Potassium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050726.pdf Draft Oral Tablet, Chewable 050726 08/2022
Azelastine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020114.pdf Draft Nasal Spray, Metered 020114 08/2022
Cetirizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021621.pdf Draft Oral Tablet, Chewable 021621 08/2022
Dantrolene Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205579.pdf Draft Intravenous For Suspension 205579 08/2022
Ethinyl Estradiol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021490.pdf Draft Oral Tablet 021490 202086 08/2022
Ethinyl Estradiol; Norethindrone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203667.pdf Draft Oral Tablet 203667 08/2022
Lamotrigine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020764.pdf Draft Oral Tablet, For Suspension 020764 08/2022
Lanthanum Carbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021468.pdf Draft Oral Tablet, Chewable 021468 08/2022
Loratadine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021891.pdf Draft Oral Tablet, Chewable 021891 08/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012541.pdf Draft Injection Injectable 012541 08/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020246.pdf Draft Injection Injectable 020246 08/2022
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 08/2022
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021475.pdf Draft Oral Tablet, Chewable 021475 08/2022
Nicotine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020385.pdf Draft Nasal Spray, Metered 020385 08/2022
Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021861.pdf Draft Nasal Spray, Metered 021861 08/2022
Oxymetazoline Hydrochloride; Tetracaine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208032.pdf Draft Nasal Spray, Metered 208032 08/2022
Prednisone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202020.pdf Draft Oral Tablet, Delayed Release 202020 08/2022
Tacrolimus https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210115.pdf Draft Oral For Suspension 210115 08/2022
Upadacitinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211675.pdf Draft Oral Tablet, Extended Release 211675 08/2022
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