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 RLD.
According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence (BE) for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate BE depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct BE 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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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 facilitate generic drug product availability and further assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, the FDA publishes product-specific guidances (PSG). PSGs describe the Agency's current thinking and expectations to develop generic drug products therapeutically equivalent to specific RLDs.
The FDA publishes PSGs to foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs.
PSGs 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.
The implementation of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 20221 (GDUFA III). with regard to issuance of PSGs is effective on October 1, 2022. Under GDUFA III, the FDA will issue PSGs consistent with the following goals:
- For complex products1,2 approved in new drug applications (NDAs) on or after October 1, 2022, a PSG will be issued for 50 percent of such NDA products within two years after the date of approval, and for 75 percent of such NDA products within three years after the date of approval.
- FDA will continue to develop PSGs for complex products approved prior to October 1, 2022, for which no PSG has been published.
- For non-complex drug products approved in NDAs on or after October 1, 2022, that contain a new chemical entity (NCE) (as described in section 505(j)(5)(F)(ii) of the FD&C Act), a PSG will be issued within two years after the date of approval for 90 percent of such products.
The FDA also evaluates drug availability and accessibility and considers public health priorities, including but not limited to, public health emergencies and drug safety and efficacy updates. In addition to these elements, the FDA continually assesses the status and outcomes of ongoing GDUFA research to ensure there are sufficient and adequate data and evidence to support the development of PSGs that align with the FDA's current scientific thinking.
Sponsors and investigators of any investigational new drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or 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.
In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or 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 PSGs 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 (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 PSGs on the Upcoming Product-Specific Guidances for Generic Drug Product Development web page
For additional information on development of generic drug products, please refer to FDA's guidance document database.
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2
Total number of currently published PSGs: 2187
128 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 | 03/24/2021 |
| Lacosamide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lacosamide_draft_Oral tab_RLD 22253_RC06-12.pdf | Draft | Oral | Tablet | 022253 | 06/14/2012 |
| Lactitol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211281.pdf | Draft | Oral | For Solution | 211281 | 11/08/2021 |
| Lamivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamivudine_draft_Oral tab_RLD 21003_RC11-07.pdf | Draft | Oral | Tablet | 021003 | 11/01/2007 |
| Lamivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamivudine_final_Oral tab_RLD 20564_RC05-08.pdf | Final | Oral | Tablet | 020564 | 05/12/2008 |
| 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 | 05/15/2019 |
| Lamivudine; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022344.pdf | Draft | Oral | Tablet | 022344 | 09/16/2019 |
| Lamivudine; Tenofovir Disoproxil Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211284.pdf | Draft | Oral | Tablet | 211284 | 08/28/2020 |
| Lamivudine; Zidovudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamivudine; Zidovudine_final_Oral tab_RLD 20857_RC05-08.pdf | Final | Oral | Tablet | 020857 | 05/12/2008 |
| Lamotrigine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020764.pdf | Draft | Oral | Tablet, For Suspension | 020764 | 08/02/2022 |
| 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 | 09/13/2018 |
| Lamotrigine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lamotrigine_tab_20241_RC1-06.pdf | Final | Oral | Tablet | 020241 | 05/01/2008 |
| 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 | 01/27/2016 |
| Lanreotide Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lanreotide Acetate_draft_Subcutaneous injection_RLD 22074_RC07-14.pdf | Draft | Subcutaneous | Solution | 022074 | 07/22/2014 |
| Lansoprazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021428.pdf | Draft | Oral | Tablet, Delayed Release, Orally Disintegrating | 021428 | 11/08/2021 |
| 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 | 07/20/2018 |
| Lanthanum Carbonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lanthanum carbonate_draft_Oral powder_RLD 204734_RC06-15.pdf | Draft | Oral | Powder | 204734 | 06/24/2015 |
| Lanthanum Carbonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021468.pdf | Draft | Oral | Tablet, Chewable | 021468 | 08/02/2022 |
| Lapatinib Ditosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022059.pdf | Draft | Oral | Tablet | 022059 | 11/17/2022 |
| Larotrectinib Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210861.pdf | Draft | Oral | Capsule | 210861 | 08/28/2020 |
| Lasmiditan Succinate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211280.pdf | Draft | Oral | Tablet | 211280 | 08/20/2021 |
| Latanoprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_206185.pdf | Draft | Ophthalmic | Emulsion | 206185 | 06/03/2020 |
| Latanoprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216472.pdf | Draft | Ophthalmic | Solution/Drops | 216472 | 11/16/2023 |
| Latanoprost | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Latanoprost_draft_Ophthalmic solution_RLD 20597_RC07-18.pdf | Draft | Ophthalmic | Solution | 020597 | 07/20/2018 |
| Latanoprost; Netarsudil Dimesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208259.pdf | Draft | Ophthalmic | Solution/Drops | 208259 | 11/21/2019 |
| 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 | 11/28/2018 |
| Ledipasvir; Sofosbuvir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212477.pdf | Draft | Oral | Pellets | 212477 | 03/24/2021 |
| Ledipasvir; Sofosbuvir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205834.pdf | Draft | Oral | Tablet | 205834 | 05/19/2021 |
| Lefamulin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211672.pdf | Draft | Oral | Tablet | 211672 | 11/18/2020 |
| Lefamulin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211673.pdf | Draft | Intravenous | Solution | 211673 | 08/28/2020 |
| Leflunomide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Leflunomide_draft_Oral tab_RLD 20905_RC08-07.pdf | Draft | Oral | Tablet | 020905 | 08/01/2007 |
| Lemborexant | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212028.pdf | Draft | Oral | Tablet | 212028 | 11/08/2021 |
| Lenacapavir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215974.pdf | Draft | Oral | Tablet | 215974 | 02/15/2024 |
| Lenacapavir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215973.pdf | Draft | Subcutaneous | Solution | 215973 | 02/15/2024 |
| Lenalidomide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lenalidomide_draft_Oral cap_RLD 21880_RC11-13.pdf | Draft | Oral | Capsule | 021880 | 11/05/2013 |
| Lenvatinib Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lenvatinib mesylate_draft_Oral cap_RLD 206947_RC04-16.pdf | Draft | Oral | Capsule | 206947 | 04/14/2016 |
| Lesinurad | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lesinurad_draft_Oral tab_RLD 207988_RC06-16.pdf | Draft | Oral | Tablet | 207988 | 06/16/2016 |
| 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 | 11/28/2018 |
| Letermovir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Letermovir_Oral tablet_NDA 209939_RC Oct 2018.pdf | Draft | Oral | Tablet | 209939 | 11/28/2018 |
| Letrozole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020726.pdf | Draft | Oral | Tablet | 020726 | 08/20/2021 |
| 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 | 02/22/2019 |
| Leucovorin Calcium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Leucovorin Calcium_draft_Oral tab_RLD 18342_RC07-18.pdf | Draft | Oral | Tablet | 018342 | 07/20/2018 |
| Leuprolide Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021088.pdf | Draft | Implantation | Implant | 021088 | 11/08/2021 |
| Leuprolide Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020517.pdf | Draft | Injection | Injectable | 020517 020708 | 08/20/2021 |
| Leuprolide Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019732.pdf | Draft | Injection | Injectable | 019732 020011 020263 | 08/20/2021 |
| Leuprolide Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021379.pdf | Draft | Subcutaneous | Powder | 021379 021488 | 02/17/2022 |
| Leuprolide Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021731.pdf | Draft | Subcutaneous | Powder | 021731 213150 | 02/17/2022 |
| Leuprolide Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021343.pdf | Draft | Subcutaneous | Powder | 021343 | 08/20/2021 |
| Leuprolide Acetate; Norethindrone Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203696.pdf | Draft | Intramuscular, Oral | Injectable, Tablet | 203696 | 11/08/2021 |
| Leuprolide Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211488.pdf | Draft | Subcutaneous | Emulsion | 211488 | 02/16/2023 |
| Levalbuterol Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021730.pdf | Draft | Inhalation | Aerosol, Metered | 021730 | 11/16/2023 |
| Levetiracetam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levetiracetam_final_Oral tab_RLD 21035_RC10-11.pdf | Final | Oral | Tablet | 021035 | 10/28/2011 |
| 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 | 02/25/2010 |
| 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 | 02/08/2018 |
| Levetiracetam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204417.pdf | Draft | Oral | Tablet, Extended Release | 204417 | 09/16/2019 |
| Levocarnitine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levocarnitine_draft_Oral tab_RLD 018948_RC09-15.pdf | Draft | Oral | Tablet | 018948 | 09/18/2015 |
| Levocetirizine Dihydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levocetirizine Dihydrochloride_draft_Oral tab_RLD 22064_RC10-08.pdf | Draft | Oral | Tablet | 022064 | 10/01/2008 |
| Levocetirizine Dihydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levocetirizine dihydrochloride_draft_Oral tabs_RLD 209089_RC02-18.pdf | Draft | Oral | Tablet | 209089 | 02/08/2018 |
| Levofloxacin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levofloxacin_draft_Oral tab_RLD 20634_RC08-10.pdf | Draft | Oral | Tablet | 020634 | 08/30/2010 |
| 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 | 12/22/2016 |
| Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levonorgestrel_draft_Oral tab_RLD 21998 21045_RC02-11.pdf | Draft | Oral | Tablet | 021045 021998 | 02/01/2011 |
| Levonorgestrel | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021225.pdf | Draft | Intrauterine | Intrauterine Device | 021225 | 01/22/2020 |
| Levorphanol Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008720.pdf | Draft | Oral | Tablet | 008720 | 11/18/2020 |
| 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 | 12/29/2014 |
| Levothyroxine sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Levothyroxine_Sodium capsules_NDA 021924_RC Oct 2018.pdf | Draft | Oral | Capsule | 021924 | 11/28/2018 |
| Lidocaine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008048.pdf | Draft | Topical | Ointment | 080198 | 05/18/2023 |
| Lidocaine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020612.pdf | Draft | Topical | Patch | 020612 | 11/21/2019 |
| Lidocaine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207962.pdf | Draft | Topical | Patch | 207962 | 11/17/2022 |
| Lidocaine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008816.pdf | Draft | Topical | Jelly | 008816 201094 | 08/21/2023 |
| Lidocaine; Prilocaine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lidocaine; Prilocaine_draft_Topical cream_RLD 019941_RC12-14.pdf | Draft | Topical | Cream | 019941 | 12/29/2014 |
| Lifitegrast | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lifitegrast_Ophthalmic solution drops_NDA 208073_RC Oct 2018.pdf | Draft | Ophthalmic | Solution/Drops | 208073 | 11/28/2018 |
| Linaclotide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202811.pdf | Draft | Oral | Capsule | 202811 | 05/19/2022 |
| Linagliptin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Linagliptin_draft_Oral tab_RLD 201280_RC09-12.pdf | Draft | Oral | Tablet | 201280 | 09/19/2012 |
| 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 | 07/22/2014 |
| 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 | 05/16/2017 |
| Linezolid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Linezolid_draft_Oral tab_RLD 21130_RC08-10.pdf | Draft | Oral | Tablet | 021130 | 08/01/2010 |
| Linezolid | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Linezolid_final_Oral susp_RLD 21132_RC10-11.pdf | Final | Oral | Suspension | 021132 | 10/28/2011 |
| Liothyronine Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010379.pdf | Draft | Oral | Tablet | 010379 | 02/17/2022 |
| Liraglutide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022341.pdf | Draft | Subcutaneous | Solution | 022341 | 03/02/2020 |
| 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 | 10/19/2017 |
| Lisdexamfetamine Dimesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lisdexamfetamine Dimesylate_draft_Oral cap_RLD 21977_RC10-17.pdf | Draft | Oral | Capsule | 021977 | 10/19/2017 |
| Lisinopril | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lisinopril_draft_Oral tab_RLD 19777_RC01-08.pdf | Draft | Oral | Tablet | 019777 | 02/23/2008 |
| Lithium Carbonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018152.pdf | Draft | Oral | Tablet, Extended Release | 076691 | 05/18/2023 |
| Lithium Carbonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018027.pdf | Draft | Oral | Tablet, Extended Release | 018027 | 05/18/2023 |
| Lithium Carbonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017812.pdf | Draft | Oral | Capsule | 017812 | 05/18/2023 |
| Lithium Carbonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018558.pdf | Draft | Oral | Tablet | 018558 | 05/18/2023 |
| Lofexidine Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209229.pdf | Draft | Oral | Tablet | 209229 | 09/16/2019 |
| Lomitapide Mesylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203858.pdf | Draft | Oral | Capsule | 203858 | 11/18/2020 |
| Lomustine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lomustine_draft_Oral cap_RLD 017588_RC07-14.pdf | Draft | Oral | Capsule | 017588 | 07/22/2014 |
| Lonafarnib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213969.pdf | Draft | Oral | Capsule | 213969 | 08/02/2022 |
| Loperamide Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide Hydrochloride_draft_Oral susp_RLD 19487_RC03-15.pdf | Draft | Oral | Suspension | 019487 | 03/06/2015 |
| Loperamide Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide_HCl_tab_19860_RC03-15.pdf | Draft | Oral | Tablet | 019860 | 03/06/2015 |
| Loperamide Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide Hydrochloride_draft_Oral cap_RLD 021855_RC03-15.pdf | Draft | Oral | Capsule | 021855 | 03/06/2015 |
| Loperamide Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loperamide Hydrochloride_draft_Oral cap_RLD 17694_RC03-15.pdf | Draft | Oral | Capsule | 017694 | 03/06/2015 |
| 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 | 03/06/2015 |
| Loperamide Hydrochloride; Simethicone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020606.pdf | Draft | Oral | Tablet, Chewable | 020606 | 08/02/2022 |
| 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 | 09/18/2015 |
| Lopinavir; Ritonavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lopinavir; Ritonavir_final_Oral tab_RLD 21906_RC09-12.pdf | Final | Oral | Tablet | 021906 | 09/19/2012 |
| Lopinavir; Ritonavir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lopinavir; Ritonavir_draft_Oral cap_RLD 21226_RC09-12.pdf | Draft | Oral | Capsule | 021226 | 09/19/2012 |
| Loratadine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loratadine_draft_Oral cap_RLD 021952_RC04-13.pdf | Draft | Oral | Capsule | 021952 | 04/05/2013 |
| Loratadine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Loratadine_draft_Oral tab_RLD 19658_RC07-08.pdf | Draft | Oral | Tablet | 019658 | 07/01/2008 |
| Loratadine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020704.pdf | Draft | Oral | Tablet, Orally Disintegrating | 020704 | 11/08/2021 |
| Loratadine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021891.pdf | Draft | Oral | Tablet, Chewable | 021891 | 08/02/2022 |
| 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 | 02/22/2019 |
| 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 | 08/30/2010 |
| Lorazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lorazepam_draft_Oral tab_RLD 17794_RC02-10.pdf | Draft | Oral | Tablet | 017794 | 02/25/2010 |
| Lorazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214826.pdf | Draft | Oral | Capsule, Extended Release | 214826 | 05/19/2022 |
| Lorlatinib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210868.pdf | Draft | Oral | Tablet | 210868 | 11/21/2019 |
| Losartan Potassium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Losartan Potassium_final_Oral tab_RLD 20386_RC05-08.pdf | Final | Oral | Tablet | 020386 | 05/01/2008 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200738.pdf | Draft | Ophthalmic | Ointment | 200738 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208219.pdf | Draft | Ophthalmic | Gel | 208219 | 08/20/2021 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202872.pdf | Draft | Ophthalmic | Gel | 202872 | 09/16/2019 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210933.pdf | Draft | Ophthalmic | Suspension/Drops | 210933 | 08/02/2022 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020803.pdf | Draft | Ophthalmic | Suspension/Drops | 020803 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf | Draft | Ophthalmic | Suspension/Drops | 020583 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210565.pdf | Draft | Ophthalmic | Suspension/Drops | 210565 | 09/16/2019 |
| Loteprednol Etabonate; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050804.pdf | Draft | Ophthalmic | Suspension/Drops | 050804 | 02/15/2024 |
| Lovastatin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021316.pdf | Draft | Oral | Tablet, Extended Release | 021316 | 09/16/2019 |
| Loxapine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022549.pdf | Draft | Inhalation | Powder | 022549 | 05/18/2023 |
| Lubiprostone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lubiprostone_draft_Oral cap_RLD 21908_RC07-15.pdf | Draft | Oral | Capsule | 021908 | 07/17/2015 |
| Luliconazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204153.pdf | Draft | Topical | Cream | 204153 | 10/21/2022 |
| Lumasiran Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214103.pdf | Draft | Subcutaneous | Solution | 214103 | 08/21/2023 |
| Lumateperone Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209500.pdf | Draft | Oral | Capsule | 209500 | 05/19/2021 |
| Lurasidone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/Lurasidone Hydrochloride_draft_Oral tab_RLD 200603_RC12-14.pdf | Draft | Oral | Tablet | 200603 | 12/29/2014 |
| Lurbinectedin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213702.pdf | Draft | Intravenous | Powder | 213702 | 11/08/2021 |
| Lusutrombopag | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210923.pdf | Draft | Oral | Tablet | 210923 | 03/02/2020 |
| Lutetium Dotatate Lu 177 | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208700.pdf | Draft | Intravenous | Solution | 208700 | 11/21/2019 |
| Lutetium Lu-177 Vipivotide Tetraxetan | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215833.pdf | Draft | Intravenous | Solution | 215833 | 08/21/2023 |
Newly Added Guidances since February 15, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215413.pdf | Draft | Oral | Tablet, For Suspension | 215413 | 02/15/2024 |
| Adagrasib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216340.pdf | Draft | Oral | Tablet | 216340 | 02/15/2024 |
| Amoxicillin; Clarithromycin; Vonoprazan Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215152.pdf | Draft | Oral | Capsule, Tablet, Tablet | 215152 | 02/15/2024 |
| Amoxicillin; Vonoprazan Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215153.pdf | Draft | Oral | Capsule, Tablet | 215153 | 02/15/2024 |
| Baclofen | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215422.pdf | Draft | Oral | Granules | 215422 | 02/15/2024 |
| Budesonide; Formoterol Fumarate; Glycopyrrolate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212122.pdf | Draft | Inhalation | Aerosol, Metered | 212122 | 02/15/2024 |
| Caffeine; Ergotamine Tartrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_086557.pdf | Draft | Rectal | Suppository | 086557 009000 | 02/15/2024 |
| Durlobactam Sodium; Durlobactam Sodium; Sulbactam Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216974.pdf | Draft | Intravenous | Powder | 216974 | 02/15/2024 |
| Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213388.pdf | Draft | Oral | Capsule | 213388 | 02/15/2024 |
| Ferric Derisomaltose | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208171.pdf | Draft | Intravenous | Solution | 208171 | 02/15/2024 |
| Finasteride; Tadalafil | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215423.pdf | Draft | Oral | Capsule | 215423 | 02/15/2024 |
| Flotufolastat F-18 Gallium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216023.pdf | Draft | Intravenous | Solution | 216023 | 02/15/2024 |
| Formoterol Fumarate; Glycopyrrolate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208294.pdf | Draft | Inhalation | Aerosol, Metered | 208294 | 02/15/2024 |
| Lenacapavir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215974.pdf | Draft | Oral | Tablet | 215974 | 02/15/2024 |
| Lenacapavir Sodium | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215973.pdf | Draft | Subcutaneous | Solution | 215973 | 02/15/2024 |
| Mannitol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022368.pdf | Draft | Inhalation | Powder | 022368 | 02/15/2024 |
| Mannitol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202049.pdf | Draft | Inhalation | Powder | 202049 | 02/15/2024 |
| Naloxone Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208969.pdf | Draft | Nasal | Spray, Metered | 208969 | 02/15/2024 |
| Niraparib Tosylate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214876.pdf | Draft | Oral | Tablet | 214876 | 02/15/2024 |
| Olutasidenib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215814.pdf | Draft | Oral | Capsule | 215814 | 02/15/2024 |
| Oxymetazoline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212520.pdf | Draft | Ophthalmic | Solution/Drops | 212520 | 04/02/2024 |
| Rivaroxaban | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215859.pdf | Draft | Oral | For Suspension | 215859 | 02/15/2024 |
| Sertraline Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215133.pdf | Draft | Oral | Capsule | 215133 | 02/15/2024 |
| Sodium Phenylbutyrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214860.pdf | Draft | Oral | For Suspension | 214860 | 02/15/2024 |
| Sodium Phenylbutyrate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216513.pdf | Draft | Oral | Pellets | 216513 | 02/15/2024 |
| Sodium Phenylbutyrate; Taurursodiol | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216660.pdf | Draft | Oral | For Suspension | 216660 | 02/15/2024 |
| Terlipressin Acetate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022231.pdf | Draft | Intravenous | Powder | 022231 | 02/15/2024 |
| Testosterone Undecanoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213953.pdf | Draft | Oral | Capsule | 213953 | 02/15/2024 |
| Xenon Xe-129 Hyperpolarized | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214375.pdf | Draft | Inhalation | Gas | 214375 | 02/15/2024 |
| Zanamivir | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021036.pdf | Draft | Inhalation | Powder | 021036 | 02/15/2024 |
Newly Revised Guidances since February 15, 2024
| Active Ingredient (link to Specific Guidance) | URL | Type | Route | Dosage Form | RLD or RS Number | Date Recommended |
|---|---|---|---|---|---|---|
| Aclidinium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202450.pdf | Draft | Inhalation | Powder, Metered | 202450 | 02/15/2024 |
| Aclidinium Bromide; Formoterol Fumarate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210595.pdf | Draft | Inhalation | Powder, Metered | 210595 | 02/15/2024 |
| Albuterol Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205636.pdf | Draft | Inhalation | Powder, Metered | 205636 | 02/15/2024 |
| Aprepitant | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209296.pdf | Draft | Intravenous | Emulsion | 209296 216457 | 02/15/2024 |
| Betamethasone Dipropionate; Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020010.pdf | Draft | Topical | Lotion | 020010 076493 | 02/15/2024 |
| Betamethasone Dipropionate; Clotrimazole | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018827.pdf | Draft | Topical | Cream | 018827 075673 | 02/15/2024 |
| Budesonide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021949.pdf | Draft | Inhalation | Powder, Metered | 021949 | 02/15/2024 |
| Dapsone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207154.pdf | Draft | Topical | Gel | 207154 | 02/15/2024 |
| Dapsone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021794.pdf | Draft | Topical | Gel | 021794 | 02/15/2024 |
| Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050023.pdf | Draft | Ophthalmic | Suspension/Drops | 050023 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050616.pdf | Draft | Ophthalmic | Ointment | 050616 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050592.pdf | Draft | Ophthalmic | Suspension/Drops | 050592 | 02/15/2024 |
| Dexamethasone; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050818.pdf | Draft | Ophthalmic | Suspension/Drops | 050818 | 02/15/2024 |
| Diazepam | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211635.pdf | Draft | Nasal | Spray | 211635 | 02/15/2024 |
| Doxepin Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022036.pdf | Draft | Oral | Tablet | 022036 | 02/15/2024 |
| Ferric Carboxymaltose | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203565.pdf | Draft | Intravenous | Solution | 203565 | 02/15/2024 |
| Fluorometholone | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_016851.pdf | Draft | Ophthalmic | Suspension/Drops | 016851 | 02/15/2024 |
| Fluticasone Furoate; Umeclidinium Bromide; Vilanterol Trifenatate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209482.pdf | Draft | Inhalation | Powder | 209482 | 02/15/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208798.pdf | Draft | Inhalation | Powder | 208798 | 02/15/2024 |
| Fluticasone Propionate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020833.pdf | Draft | Inhalation | Powder | 020833 | 02/15/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021077.pdf | Draft | Inhalation | Powder | 021077 | 02/15/2024 |
| Fluticasone Propionate; Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208799.pdf | Draft | Inhalation | Powder | 208799 | 02/15/2024 |
| Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060613.pdf | Draft | Otic | Suspension/Drops | 060613 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf | Draft | Ophthalmic | Suspension/Drops | 020583 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_200738.pdf | Draft | Ophthalmic | Ointment | 200738 | 02/15/2024 |
| Loteprednol Etabonate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020803.pdf | Draft | Ophthalmic | Suspension/Drops | 020803 | 02/15/2024 |
| Loteprednol Etabonate; Tobramycin | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050804.pdf | Draft | Ophthalmic | Suspension/Drops | 050804 | 02/15/2024 |
| Mometasone Furoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf | Draft | Inhalation | Powder | 021067 | 02/15/2024 |
| Nilotinib Hydrochloride | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022068.pdf | Draft | Oral | Capsule | 022068 | 02/15/2024 |
| Salmeterol Xinafoate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020692.pdf | Draft | Inhalation | Powder | 020692 | 02/15/2024 |
| Umeclidinium Bromide | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205382.pdf | Draft | Inhalation | Powder | 205382 | 02/15/2024 |
| Umeclidinium Bromide; Vilanterol Trifenatate | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203975.pdf | Draft | Inhalation | Powder | 203975 | 02/15/2024 |
| Vandetanib | https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022405.pdf | Draft | Oral | Tablet | 022405 | 02/15/2024 |