U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. PSG Database

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initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).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.
In addition to GDUFA III PSG goals, the FDA considers several factors when prioritizing PSG development. The FDA evaluates the generic industries and other stakeholders' interest in products that do not have a PSG through controlled correspondences, public requests, and pre-ANDA meeting requests.

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.

1GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III Commitment Letter)

2Classifying Approved New Drug Products and Drug-device combination Products as Complex Products for Generic Drug Development Purposes (CDER MAPP 5240.10)

Total number of currently published PSGs: 2187

Product-Specific Guidances for Specific Products Arranged by Active Ingredient

Search by Active Ingredient or by RLD or RS Number

176 record(s) found for 'M'

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Macimorelin acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Macimorelin Acetate_Oral solution_NDA 205598_RC Oct 2018.pdf Draft Oral Solution 205598 11/28/2018
Macitentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Macitentan_draft_Oral tab_RLD 204410_RC06-15.pdf Draft Oral Tablet 204410 06/24/2015
Magnesium Hydroxide;Omeprazole;Sodium Bicarbonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Omeprazole;_Sodium_Bicarbonate;_Magnesium_Hydroxide_chew_21850_RC2-08.pdf Draft Oral Tablet, Chewable 021850 04/06/2008
Magnesium Sulfate; Potassium Chloride; Sodium Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213135.pdf Draft Oral Tablet 213135 11/17/2022
Malathion https://www.accessdata.fda.gov/drugsatfda_docs/psg/Malathion_draft_Topical lotion_RLD 18613_RC06-12.pdf Draft Topical Lotion 018613 06/14/2012
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
Maralixibat Chloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214662.pdf Draft Oral Solution 214662 08/21/2023
Maraviroc https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022128.pdf Draft Oral Tablet 022128 08/28/2020
Maribavir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215596.pdf Draft Oral Tablet 215596 05/18/2023
Mavacamten https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214998.pdf Draft Oral Capsule 214998 08/21/2023
Mebendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mebendazole_draft_Oral tab chewable_RLD 17481_RC02-09.pdf Draft Oral Tablet, Chewable 017481 02/01/2009
Mebendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mebendazole_draft_Oral tab chewable_RLD 208398_RC02-18.pdf Draft Oral Tablet, Chewable 208398 02/08/2018
Mecamylamine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mecamylamine hydrochloride_draft_Oral tab_RLD 010251_RC07-18.pdf Draft Oral Tablet 010251 07/20/2018
Mechlorethamine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202317.pdf Draft Topical Gel 202317 02/16/2023
Meclizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meclizine Hydrochloride_draft_Oral tab chewable_RLD 10721_RC04-10.pdf Draft Oral Tablet, Chewable 010721 04/20/2010
Meclizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meclizine_tab_10721_RC12-09.pdf Draft Oral Tablet 010721 12/17/2009
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_012541.pdf Draft Injection Injectable 012541 08/02/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020246.pdf Draft Injection Injectable 020246 08/02/2022
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011839.pdf Draft Oral Tablet 011839 11/21/2019
Mefenamic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mefenamic Acid_draft_Oral cap_RLD 15034_RC02-10.pdf Draft Oral Capsule 015034 02/25/2010
Mefloquine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mefloquine Hydrochloride_final_Oral tab_RLD 76175_RC05-08.pdf Final Oral Tablet 076175 05/12/2008
Megestrol Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Megestrol Acetate_draft_Oral susp_RLD 20264_RC02-10.pdf Draft Oral Suspension 020264 02/25/2010
Megestrol Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Megestrol Acetate_draft_Oral susp_RLD 21778_RC02-10.pdf Draft Oral Suspension 021778 02/25/2010
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meloxicam_draft_Oral cap_RLD 207233_RC06-16.pdf Draft Oral Capsule 207233 06/16/2016
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meloxicam_final_Oral susp_RLD 21530_RC05-08.pdf Final Oral Suspension 021530 05/12/2008
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meloxicam_final_Oral tab_RLD 20938_RC05-08.pdf Final Oral Tablet 020938 05/12/2008
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 08/02/2022
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211210.pdf Draft Oral Tablet, Orally Disintegrating 211210 11/21/2019
Melphalan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Melphalan_draft_Oral tab_RLD 14691_RC07-09.pdf Draft Oral Tablet 014691 07/01/2009
Melphalan Flufenamide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214383.pdf Draft Intravenous Powder 214383 11/17/2022
Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Memantine Hydrochloride_draft_Oral tab_RLD 21487_RC12-14.pdf Draft Oral Tablet 021487 12/29/2014
Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Memantine Hydrochloride_draft_Oral cap ER_RLD 22525_RC12-14.pdf Draft Oral Capsule, Extended Release 022525 12/29/2014
Menthol; Methyl Salicylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022029.pdf Draft Topical Patch 022029 11/21/2019
Meprobamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meprobamate_final_Oral tab_RLD 009698_RC10-11.pdf Final Oral Tablet 009698 10/28/2011
Mercaptopurine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mercaptopurine_draft_Oral tab_RLD 040528_RC04-11.pdf Draft Oral Tablet 040528 04/01/2011
Mercaptopurine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mercaptopurine_draft_Oral susp_RLD 205919_RC01-16.pdf Draft Oral Suspension 205919 01/27/2016
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesalamine_draft_Oral cap DR_RLD 204412_RC06-16.pdf Draft Oral Capsule, Delayed Release 204412 06/16/2016
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesalamine_draft_Oral cap ER_RLD 20049_RC10-17.pdf Draft Oral Capsule, Extended Release 020049 10/19/2017
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesalamine_draft_Oral tab DR_RLD 19651_RC10-16.pdf Draft Oral Tablet, Delayed Release 019651 10/04/2016
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesalamine_draft_Oral tab DR_RLD 21830_RC06-16.pdf Draft Oral Tablet, Delayed Release 021830 06/16/2016
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesalamine_draft_Oral tab DR_RLD 22000_RC06-16.pdf Draft Oral Tablet, Delayed Release 022000 06/16/2016
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesalamine_draft_Rectal enema_RLD 19618_RC01-08.pdf Draft Rectal Enema 019618 02/23/2008
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesalamine_draft_Rectal supp_RLD 21252_RC03-13.pdf Draft Rectal Suppository 021252 03/01/2013
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022301.pdf Draft Oral Capsule, Extended Release 022301 09/16/2019
Mesna https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesna_draft_Oral tab_RLD 20855_RC11-13.pdf Draft Oral Tablet 020855 11/05/2013
Mestranol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mestranol; Norethindrone_draft_Oral tab_RLD 16659_RC04-10.pdf Draft Oral Tablet 016659 04/20/2010
Metaxalone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metaxalone_draft_Oral tab_RLD 13217_RC11-18.pdf Draft Oral Tablet 013217 11/28/2018
Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin_HCl_ERtab_21574_RC3-09.pdf Draft Oral Tablet, Extended Release 021574 02/25/2010
Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin Hydrochloride_draft_Oral tab ER_RLD 21748_RC02-10.pdf Draft Oral Tablet, Extended Release 021748 02/25/2010
Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin Hydrochloride_draft_Oral tab_RLD 20357_RC07-08.pdf Draft Oral Tablet 020357 07/01/2008
Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin Hydrochloride_final_Oral tab ER_RLD 21202_RC05-08.pdf Final Oral Tablet, Extended Release 021202 05/12/2008
Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212595.pdf Draft Oral For Suspension, Extended Release 212595 06/03/2020
Metformin Hydrochloride; Pioglitazone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin Hydrochloride; Pioglitazone Hydrochloride_final_Oral tab_RLD 21842_RC05-08.pdf Final Oral Tablet 021842 05/12/2008
Metformin Hydrochloride; Pioglitazone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin Hydrochloride; Pioglitazone Hydrochloride_draft_Oral tab ER_RLD 22024_RC03-10.pdf Draft Oral Tablet, Extended Release 022024 03/19/2010
Metformin Hydrochloride; Repaglinide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022386.pdf Draft Oral Tablet 022386 11/21/2019
Metformin Hydrochloride; Sitagliptin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin Hydrochloride; Sitagliptin Phosphate_draft_Oral tab ER_RLD 202270_RC07-14.pdf Draft Oral Tablet, Extended Release 202270 07/22/2014
Metformin Hydrochloride; Sitagliptin Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sitagliptin_Phosphate;_Metformin_HCl_tab_22044_RC9-08.pdf Draft Oral Tablet 022044 09/01/2008
Metformin Hydrochloride;Saxagliptin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin Hydrochloride; Saxagliptin_draft_Oral tab ER_RLD 200678_RC03-12.pdf Draft Oral Tablet, Extended Release 200678 03/28/2012
Methadone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methadone_HCl_tab_06134_17058_RC7-08.pdf Draft Oral Tablet 006134 017058 07/01/2008
Methazolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methazolamide_draft_Oral tab_RLD 040062_RC06-15.pdf Draft Oral Tablet 040062 06/24/2015
Methenamine Hippurate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methenamine Hippurate_draft_Oral tab_RLD 17681_RC11-13.pdf Draft Oral Tablet 017681 11/05/2013
Methimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methimazole_draft_Oral tab_RLD 40350_RC02-10.pdf Draft Oral Tablet 040350 02/25/2010
Methocarbamol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methocarbamol_draft_Oral tab_RLD 11011_RC11-13.pdf Draft Oral Tablet 011011 11/05/2013
Methotrexate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methotrexate Sodium_final_Oral tab_RLD 08085_RC10-11.pdf Final Oral Tablet 008085 10/28/2011
Methotrexate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methotrexate Sodium_final_Oral tab_RLD 40385_RC10-11.pdf Final Oral Tablet 040385 10/28/2011
Methoxsalen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methoxsalen_draft_Oral cap_RLD 09048_RC04-10.pdf Draft Oral Capsule 009048 04/20/2010
Methoxsalen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methoxsalen_draft_Oral cap_RLD 19600_RC07-17.pdf Draft Oral Capsule 019600 07/13/2017
Methscopolamine bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methscopolamine bromide_draft_Oral tab_RLD 040624_RC07-18.pdf Draft Oral Tablet 040624 07/20/2018
Methsuximide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methsuximide Oral Capsules NDA 010596 RC Feb 2019.pdf Draft Oral Capsule 010596 02/22/2019
Methylergonovine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylergonovine maleate_draft_Oral tab_RLD 006035_RC06-16.pdf Draft Oral Tablet 006035 06/16/2016
Methylnaltrexone Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylnaltrexone bromide_draft_Oral tab_RLD 208271_RC05-17.pdf Draft Oral Tablet 208271 05/16/2017
Methylphenidate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021514.pdf Draft Transdermal Film, Extended Release 021514 11/21/2019
Methylphenidate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205489.pdf Draft Oral Tablet, Orally Disintegrating, Extended Release 205489 11/08/2021
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205831.pdf Draft Oral Capsule, Extended Release 205831 06/03/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021284.pdf Draft Oral Capsule, Extended Release 021284 06/03/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021259.pdf Draft Oral Capsule, Extended Release 021259 06/03/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018029.pdf Draft Oral Tablet, Extended Release 018029 06/03/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209311.pdf Draft Oral Capsule, Extended Release 209311 06/03/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212038.pdf Draft Oral Capsule, Extended Release 212038 06/03/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate Hydrochloride_draft_Oral tab ER_RLD 21121_RC07-18.pdf Draft Oral Tablet, Extended Release 021121 07/20/2018
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate Hydrochloride_draft_Oral tab_RLD 10187_RC02-10.pdf Draft Oral Tablet 010187 02/25/2010
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021475.pdf Draft Oral Tablet, Chewable 021475 08/02/2022
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate Hydrochloride_draft_Oral suspER_RLD 202100_RC12-14.pdf Draft Oral Suspension, Extended Release 202100 12/23/2014
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207960.pdf Draft Oral Tablet, Extended Release, Chewable 207960 11/18/2020
Methylprednisolone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylprednisolone Oral Tablet NDA 11153 PSG Page RV May 2019.pdf Draft Oral Tablet 011153 05/15/2019
Methylprednisolone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011757.pdf Draft Injection Injectable 011757 02/17/2022
Methyltestosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methyltestosterone_draft_Oral cap_RLD 083976_RC06-13.pdf Draft Oral Capsule 083976 06/19/2013
Metoclopramide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metoclopramide Hydrochloride_final_Oral tab_RLD 17854_RC10-11.pdf Final Oral Tablet 017854 10/28/2011
Metoclopramide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022246.pdf Draft Oral Tablet, Orally Disintegrating 022246 11/08/2021
Metoclopramide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209388.pdf Draft Nasal Spray, Metered 209388 05/19/2021
Metolazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metolazone_draft_Oral tab_RLD 17386_RC11-10.pdf Draft Oral Tablet 017386 11/26/2010
Metoprolol Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019962.pdf Draft Oral Tablet, Extended Release 019962 08/28/2020
Metoprolol Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210428.pdf Draft Oral Capsule, Extended Release 210428 05/19/2022
Metoprolol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017963.pdf Draft Oral Tablet 017963 06/03/2020
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020208.pdf Draft Vaginal Gel 020208 021806 10/21/2022
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205223.pdf Draft Vaginal Gel 205223 10/21/2022
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metronidazole_draft_Oral tab_RLD 12623_RC09-10.pdf Draft Oral Tablet 012623 09/30/2010
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020531.pdf Draft Topical Cream 020531 10/21/2022
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020743.pdf Draft Topical Cream 020743 10/21/2022
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021789.pdf Draft Topical Gel 021789 10/21/2022
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020901.pdf Draft Topical Lotion 020901 10/21/2022
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metronidazole_draft_Oral cap_RLD 020334_RC01-16.pdf Draft Oral Capsule 020334 01/27/2016
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019737.pdf Draft Topical Gel 019737 10/21/2022
Metyrosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metyrosine_draft_Oral cap_RLD 017871_RC07-18.pdf Draft Oral Capsule 017871 07/20/2018
Mexiletine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018873.pdf Draft Oral Capsule 074377 03/02/2020
Miconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Buccal_Tablet_50mg_NDA_22404_RV_Feb_2019.pdf Draft Buccal Tablet 022404 02/22/2019
Miconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Nitrate_vagcrm2_17450_RC10-09.pdf Draft Vaginal Cream 2% 017450 10/01/2009
Miconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Nitrate_vagcrm4 _20827_RC10-09.pdf Draft Vaginal Cream 4% 020827 10/01/2009
Miconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Nitrate_vagsupp100mg_18520_ RC10-09.pdf Draft Vaginal Suppository 100 mg 018520 10/01/2009
Miconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Nitrate_vagsupp200mg_18888_ RC10-09.pdf Draft Vaginal Suppository 200 mg 018888 10/01/2009
Miconazole Nitrate; White Petrolatum; Zinc Oxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021026.pdf Draft Topical Ointment 021026 11/17/2022
Midazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211321.pdf Draft Nasal Spray 211321 05/19/2021
Midazolam Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216359.pdf Draft Intramuscular Solution 216359 08/21/2023
Midodrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Midodrine_HCl_tab_19815_RC8-08.pdf Draft Oral Tablet 019815 08/01/2008
Midostaurin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207997.pdf Draft Oral Capsule 207997 05/19/2022
Mifepristone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202107.pdf Draft Oral Tablet 202107 11/21/2019
Mifepristone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020687.pdf Draft Oral Tablet 020687 11/21/2019
Migalastat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208623.pdf Draft Oral Capsule 208623 11/21/2019
Miglitol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miglitol_oral tablet_020682_RC06-15.pdf Draft Oral Tablet 020682 06/24/2015
Miglustat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miglustat_cap_21348_RC5-06.pdf Final Oral Capsule 021348 05/12/2008
Milnacipran Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Milnacipran_HCl_tab_22256_RV09-11.pdf Draft Oral Tablet 022256 09/01/2011
Miltefosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miltefosine_draft_Oral cap_RLD 204684_RC09-18.pdf Draft Oral Capsule 204684 09/13/2018
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minocycline HCl_Dental ER Powder_50781_ RC03-15.pdf Draft Dental Powder, Extended Release 050781 03/06/2015
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minocycline_HCl_ERcap_201922_RC04-13.pdf Draft Oral Capsule, Extended Release 201922 04/05/2013
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minocyline HCl_oral tablet_NDA 50451_RV05-17.pdf Draft Oral Tablet 050451 07/13/2017
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minocyline HCl_oral capsule_ANDA 63009, 63011_RV05-17.pdf Draft Oral Capsule 050649 063009 07/13/2017
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minocycline hydrochloride_oral ER tablet_050808_RV09-15.pdf Draft Oral Tablet, Extended Release 050808 09/18/2015
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212379.pdf Draft Topical Aerosol, Foam 212379 11/08/2021
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213690.pdf Draft Topical Aerosol, Foam 213690 11/08/2021
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209269.pdf Draft Oral Tablet, Extended Release 209269 11/08/2021
Minoxidil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minoxidil_fmaerosol_OTC_ 21812_RC5-10.pdf Draft Topical Aerosol, Foam 021812 02/23/2011
Minoxidil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minoxidil_sol_ 19501_OTC_RC5-10.pdf Draft Topical Solution 019501 05/20/2010
Minoxidil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minoxidil_sol_ 20834_OTC_RC5-10.pdf Draft Topical Solution 020834 05/20/2010
Minoxidil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minoxidil_oral tablet_NDA 018154_RV05-17.pdf Draft Oral Tablet 018154 07/13/2017
Mirabegron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202611.pdf Draft Oral Tablet, Extended Release 202611 02/16/2023
Mirabegron https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213801.pdf Draft Oral For Suspension, Extended Release 213801 02/17/2022
Mirtazapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021208.pdf Draft Oral Tablet, Orally Disintegrating 021208 11/08/2021
Mirtazapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mirtazapine_Oral Tablet_020415_RV03.pdf Draft Oral Tablet 020415 03/06/2015
Misoprostol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Misoprostol_tab_19268_RC2-10.pdf Draft Oral Tablet 019268 02/25/2010
Mitapivat Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_216196.pdf Draft Oral Tablet 216196 08/21/2023
Mitotane https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mitotane_Tabs_016885_RC04-13.pdf Draft Oral Tablet 016885 04/05/2013
Mobocertinib Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215310.pdf Draft Oral Capsule 215310 08/21/2023
Modafinil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Modafinil_tab_20717_RC8-05.pdf Final Oral Tablet 020717 05/12/2008
Moexipril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Moexipril_HCl_tab_20312_RC5-05.pdf Final Oral Tablet 020312 05/12/2008
Molindone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017111.pdf Draft Oral Tablet 017111 11/21/2019
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021067.pdf Draft Inhalation Powder 021067 02/15/2024
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205641.pdf Draft Inhalation Aerosol, Metered 205641 11/16/2023
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone furoate_topical cream_NDA 019625_RC04-16.pdf Draft Topical Cream 019625 04/14/2016
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone furoate_topical lotion_RLD 19796_RC04-16.pdf Draft Topical Lotion 019796 04/14/2016
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone furoate_ topical ointment_RLD 019543_RC01-16.pdf Draft Topical Ointment 019543 01/27/2016
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020762.pdf Draft Nasal Spray, Metered 020762 05/18/2023
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_215712.pdf Draft Nasal Spray, Metered 215712 11/17/2022
Mometasone Furoate; Olopatadine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211746.pdf Draft Nasal Spray, Metered 211746 08/21/2023
Monomethyl Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210296.pdf Draft Oral Capsule, Delayed Release 210296 03/24/2021
Montelukast Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Montelukast_gran_21409_RC7-08.pdf Draft Oral Granule 021409 07/01/2008
Montelukast Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Montelukast_Sodium_tab_20829_RC8-08.pdf Draft Oral Tablet 020829 07/01/2008
Montelukast Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Montelukast_Sodium_chewtab_20830_RC12-05.pdf Draft Oral Tablet, Chewable 020830 07/01/2008
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate_draft_Oral tab ER_RLD 206544_RC09-18.pdf Draft Oral Tablet, Extended Release 206544 09/13/2018
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate_oral solution_RLD 022195_RC09-16.pdf Draft Oral Solution 022195 10/04/2016
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine_Sulfate_ERtab_19516_RC12-10.pdf Draft Oral Tablet, Extended Release 019516 12/23/2010
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine_Sulfate_tab_ 22207_RC2-10.pdf Draft Oral Tablet 022207 02/25/2010
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine_Suflate_ERCap_21260_RC11-10.pdf Draft Oral Capsule, Extended Release 021260 11/26/2010
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate_oral ER capsule_NDA 020616_RV11-17.pdf Draft Oral Capsule, Extended Release 020616 02/08/2018
Morphine sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate_draft_Oral cap_RLD 208603_RC09-18.pdf Draft Oral Tablet, Extended Release 208603 09/13/2018
Morphine Sulfate;Naltrexone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate; Naltrexone HCL_oral ER capsule_NDA 022321_RV07-18.pdf Draft Oral Capsule, Extended Release 022321 07/20/2018
Moxidectin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210867.pdf Draft Oral Tablet 210867 03/02/2020
Moxifloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Moxifloxacin_HCl_tab_21085_RC7-08.pdf Draft Oral Tablet 021085 07/01/2008
Moxifloxacin hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Moxifloxacin hydrochloride_draft_Ophthalmic solution drops_RLD 021598_RC07-18.pdf Draft Ophthalmic Solution/Drops 021598 07/20/2018
Mupirocin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050591.pdf Draft Topical Ointment 050591 10/21/2022
Mupirocin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050746.pdf Draft Topical Cream 050746 10/21/2022
Mupirocin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mupirocin_ Calcium_nasal_oint_50703_RC06-10.pdf Draft Nasal Ointment 050703 06/30/2010
Mycophenolate Mofetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050759.pdf Draft Oral For Suspension 050759 02/17/2022
Mycophenolate Mofetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050722.pdf Draft Oral Capsule 050722 08/28/2020
Mycophenolate Mofetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050723.pdf Draft Oral Tablet 050723 08/28/2020
Mycophenolic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mycophenolic Acid_draft_Oral tab DR_RLD 50791_RC11-18.pdf Draft Oral Tablet, Delayed Release 050791 11/28/2018

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
Back to Top