Product-Specific Guidances for Generic Drug Development

Disclaimer: Due to April 2019 systemwide upgrades to www.fda.gov, the filenames for product-specific guidances on this web page may not match the corresponding guidance titles. In such cases, the name on the document correctly identifies the title of the guidance. These discrepancies will be corrected as soon as possible.


To successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be: pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use; bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient; and, consequently, therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug.

According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate bioequivalence depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach available among those set forth in 21 CFR 320.24. As the initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (August 2021).

To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances describing the Agency's current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs.

FDA publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs.

These guidances are published in an incremental manner and listed below in alphabetical order according to the active ingredient's name. The most recently published guidances (new and revised) are listed below.

Additionally, as part of FDA's commitments under the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), FDA will publish guidances for reference listed drugs that are (1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to the earliest lawful ANDA filing date. 1 This goal does not include complex products as defined in the GDUFA II Commitment Letter. FDA will strive to issue guidance for a complex product as soon as scientific recommendations are available.

In addition to the provided information, sponsors and investigators of any Investigational New Drug (IND)-exempt pharmacokinetic (PK) studies, pharmacodynamic (PD) studies, or bioequivalence (BE) and/or bioavailability (BA) studies involving human subjects in support of an ANDA should refer to the current RLD labeling, including BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS sections. This information should be considered during study design and conduct; including attention to appropriate subject screening and selection, inclusion and exclusion criteria, and appropriate clinical safety monitoring.

Some of the product-specific guidances include discussion regarding data formats. Please note that under section 745A(a) of the Federal Food, Drug, and Cosmetic Act, separate Agency-wide guidances specify the electronic formats, subject matter, and scope of applicability for certain submissions, including submissions to ANDAs. As these are finalized guidances and subject to described timetables for implementation, these guidances are binding and the electronic format(s) specified must be used for submissions to ANDAs. Questions and general information regarding the preparation of submissions in electronic format may be directed to CDER at esub@fda.hhs.gov. Questions regarding submission of datasets to CDER may be sent to edata@fda.hhs.gov.

COMMENTS: The Agency is seeking feedback and considers comments to the docket on these guidances. You may submit comments on any guidance at any time as follows: Submit electronic comments to Docket FDA-2007-D-0369. For further information on submitting electronic comments, refer to the regulations.gov website (https://www.regulations.gov/help). You may also mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All submissions received must include the Docket No. [FDA-2007-D-0369]. Please contact the Regulations.gov Help Desk at 1-877-378-5457 (toll free) for assistance regarding submissions.

The FDA posts plans for issuing new or revised product-specific guidances on the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page.

For additional information on development of generic drug products, please refer to FDA’s biopharmaceutics guidances.

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

 

 

 

Total number of currently published PSGs: 1921

Product-Specific Guidances for Specific Products Arranged by Active Ingredient


Search by Active Ingredient or by RLD or RS Number


158 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 11/2018
Macitentan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Macitentan_draft_Oral tab_RLD 204410_RC06-15.pdf Draft Oral Tablet 204410 06/2015
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 02/2008
Malathion https://www.accessdata.fda.gov/drugsatfda_docs/psg/Malathion_draft_Topical lotion_RLD 18613_RC06-12.pdf Draft Topical Lotion 018613 06/2012
Maraviroc https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022128.pdf Draft Oral Tablet 022128 08/2020
Mebendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mebendazole_draft_Oral tab chewable_RLD 17481_RC02-09.pdf Draft Oral Tablet, Chewable 017481 02/2009
Mebendazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mebendazole_draft_Oral tab chewable_RLD 208398_RC02-18.pdf Draft Oral Tablet, Chewable 208398 02/2018
Mecamylamine hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mecamylamine hydrochloride_draft_Oral tab_RLD 010251_RC07-18.pdf Draft Oral Tablet 010251 07/2018
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 04/2010
Meclizine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meclizine_tab_10721_RC12-09.pdf Draft Oral Tablet 010721 12/2009
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Medroxyprogesterone Acetate_draft_Intramuscular susp_RLD 012541_RC06-13.pdf Draft Intramuscular Suspension 012541 06/2013
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Medroxyprogesterone Acetate_draft_Intramuscular susp_RLD 020246_RC12-16.pdf Draft Intramuscular Suspension 020246 12/2016
Medroxyprogesterone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_011839.pdf Draft Oral Tablet 011839 11/2019
Mefenamic Acid https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mefenamic Acid_draft_Oral cap_RLD 15034_RC02-10.pdf Draft Oral Capsule 015034 02/2010
Mefloquine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mefloquine Hydrochloride_final_Oral tab_RLD 76175_RC05-08.pdf Final Oral Tablet 076175 05/2008
Megestrol Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Megestrol Acetate_draft_Oral susp_RLD 20264_RC02-10.pdf Draft Oral Suspension 020264 02/2010
Megestrol Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Megestrol Acetate_draft_Oral susp_RLD 21778_RC02-10.pdf Draft Oral Suspension 021778 02/2010
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meloxicam_draft_Oral cap_RLD 207233_RC06-16.pdf Draft Oral Capsule 207233 06/2016
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meloxicam_final_Oral susp_RLD 21530_RC05-08.pdf Final Oral Suspension 021530 05/2008
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meloxicam_final_Oral tab_RLD 20938_RC05-08.pdf Final Oral Tablet 020938 05/2008
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210583.pdf Draft Intravenous Solution 210583 05/2021
Meloxicam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211210.pdf Draft Oral Tablet, Orally Disintegrating 211210 11/2019
Melphalan https://www.accessdata.fda.gov/drugsatfda_docs/psg/Melphalan_draft_Oral tab_RLD 14691_RC07-09.pdf Draft Oral Tablet 014691 07/2009
Memantine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Memantine Hydrochloride_draft_Oral tab_RLD 21487_RC12-14.pdf Draft Oral Tablet 021487 12/2014
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 12/2014
Menthol; Methyl Salicylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022029.pdf Draft Topical Patch 022029 11/2019
Meprobamate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Meprobamate_final_Oral tab_RLD 009698_RC10-11.pdf Final Oral Tablet 009698 10/2011
Mercaptopurine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mercaptopurine_draft_Oral tab_RLD 040528_RC04-11.pdf Draft Oral Tablet 040528 04/2011
Mercaptopurine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mercaptopurine_draft_Oral susp_RLD 205919_RC01-16.pdf Draft Oral Suspension 205919 01/2016
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 06/2016
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 10/2017
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 10/2016
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 06/2016
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 06/2016
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesalamine_draft_Rectal enema_RLD 19618_RC01-08.pdf Draft Rectal Enema 019618 01/2008
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesalamine_draft_Rectal supp_RLD 21252_RC03-13.pdf Draft Rectal Suppository 021252 03/2013
Mesalamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022301.pdf Draft Oral Capsule, Extended Release 022301 09/2019
Mesna https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mesna_draft_Oral tab_RLD 20855_RC11-13.pdf Draft Oral Tablet 020855 11/2013
Mestranol; Norethindrone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mestranol; Norethindrone_draft_Oral tab_RLD 16659_RC04-10.pdf Draft Oral Tablet 016659 04/2010
Metaxalone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metaxalone_draft_Oral tab_RLD 13217_RC11-18.pdf Draft Oral Tablet 013217 11/2018
Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin_HCl_ERtab_21574_RC3-09.pdf Draft Oral Tablet, Extended Release 021574 02/2010
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 02/2010
Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metformin Hydrochloride_draft_Oral tab_RLD 20357_RC07-08.pdf Draft Oral Tablet 020357 07/2008
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 05/2008
Metformin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212595.pdf Draft Oral For Suspension, Extended Release 212595 06/2020
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 05/2008
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 03/2010
Metformin Hydrochloride; Repaglinide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022386.pdf Draft Oral Tablet 022386 11/2019
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 07/2014
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 09/2008
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 03/2012
Methadone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methadone_HCl_tab_06134_17058_RC7-08.pdf Draft Oral Tablet 006134 017058 07/2008
Methazolamide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methazolamide_draft_Oral tab_RLD 040062_RC06-15.pdf Draft Oral Tablet 040062 06/2015
Methenamine Hippurate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methenamine Hippurate_draft_Oral tab_RLD 17681_RC11-13.pdf Draft Oral Tablet 017681 11/2013
Methimazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methimazole_draft_Oral tab_RLD 40350_RC02-10.pdf Draft Oral Tablet 040350 02/2010
Methocarbamol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methocarbamol_draft_Oral tab_RLD 11011_RC11-13.pdf Draft Oral Tablet 011011 11/2013
Methotrexate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methotrexate Sodium_final_Oral tab_RLD 08085_RC10-11.pdf Final Oral Tablet 008085 10/2011
Methotrexate Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methotrexate Sodium_final_Oral tab_RLD 40385_RC10-11.pdf Final Oral Tablet 040385 10/2011
Methoxsalen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methoxsalen_draft_Oral cap_RLD 09048_RC04-10.pdf Draft Oral Capsule 009048 04/2010
Methoxsalen https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methoxsalen_draft_Oral cap_RLD 19600_RC07-17.pdf Draft Oral Capsule 019600 07/2017
Methscopolamine bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methscopolamine bromide_draft_Oral tab_RLD 040624_RC07-18.pdf Draft Oral Tablet 040624 07/2018
Methsuximide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methsuximide Oral Capsules NDA 010596 RC Feb 2019.pdf Draft Oral Capsule 010596 02/2019
Methylergonovine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylergonovine maleate_draft_Oral tab_RLD 006035_RC06-16.pdf Draft Oral Tablet 006035 06/2016
Methylnaltrexone Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylnaltrexone bromide_draft_Oral tab_RLD 208271_RC05-17.pdf Draft Oral Tablet 208271 05/2017
Methylphenidate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate_draft_Orally disintegrating tab ER_RLD 205489_RC07-18.pdf Draft Oral Tablet, Orally Disintegrating, Extended Release 205489 07/2018
Methylphenidate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021514.pdf Draft Transdermal Film, Extended Release 021514 11/2019
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 07/2018
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate Hydrochloride_draft_Oral tab_RLD 10187_RC02-10.pdf Draft Oral Tablet 010187 02/2010
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylphenidate Hydrochloride_draft_Oral tab chewable_RLD 21475_RC12-09.pdf Draft Oral Tablet, Chewable 021475 12/2009
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 12/2014
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209311.pdf Draft Oral Capsule, Extended Release 209311 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212038.pdf Draft Oral Capsule, Extended Release 212038 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205831.pdf Draft Oral Capsules, Extended Release 205831 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021284.pdf Draft Oral Capsule, Extended Release 021284 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021259.pdf Draft Oral Capsule, Extended Release 021259 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018029.pdf Draft Oral Tablet, Extended Release 018029 06/2020
Methylphenidate Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207960.pdf Draft Oral Tablet, Extended Release, Chewable 207960 11/2020
Methylprednisolone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylprednisolone Oral Tablet NDA 11153 PSG Page RV May 2019.pdf Draft Oral Tablet 011153 05/2019
Methylprednisolone Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methylprednisolone Acetate_draft_Injection susp_RLD 11757_RC12-14.pdf Draft Injection Suspension 011757 12/2014
Methyltestosterone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Methyltestosterone_draft_Oral cap_RLD 083976_RC06-13.pdf Draft Oral Capsule 083976 06/2013
Metoclopramide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metoclopramide Hydrochloride_draft_Oral tab OD_RLD 22246_RC09-10.pdf Draft Oral Tablet, Orally Disintegrating 022246 09/2010
Metoclopramide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metoclopramide Hydrochloride_final_Oral tab_RLD 17854_RC10-11.pdf Final Oral Tablet 017854 10/2011
Metoclopramide Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209388.pdf Draft Nasal Spray, Metered 209388 05/2021
Metolazone https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metolazone_draft_Oral tab_RLD 17386_RC11-10.pdf Draft Oral Tablet 017386 11/2010
Metoprolol Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019962.pdf Draft Oral Tablet, Extended Release 019962 08/2020
Metoprolol Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metoprolol succinate_Oral extended release capsule_NDA 210428_RC Nov 2018.pdf Draft Oral Capsule, Extended Release 210428 11/2018
Metoprolol Tartrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017963.pdf Draft Oral Tablet 017963 06/2020
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020208.pdf Draft Vaginal Gel 021806 020208 06/2020
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019737.pdf Draft Topical Gel 0.75% 019737 09/2019
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205223.pdf Draft Vaginal Gel 205223 06/2020
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metronidazole_draft_Oral tab_RLD 12623_RC09-10.pdf Draft Oral Tablet 012623 09/2010
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020531.pdf Draft Topical Cream 020531 09/2019
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020743.pdf Draft Topical Cream 020743 09/2019
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021789.pdf Draft Topical Gel 1% 021789 09/2019
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020901.pdf Draft Topical Lotion 020901 09/2019
Metronidazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metronidazole_draft_Oral cap_RLD 020334_RC01-16.pdf Draft Oral Capsule 020334 01/2016
Metyrosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Metyrosine_draft_Oral cap_RLD 017871_RC07-18.pdf Draft Oral Capsule 017871 07/2018
Mexiletine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_018873.pdf Draft Oral Capsule 074377 03/2020
Miconazole https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Buccal_Tablet_50mg_NDA_22404_RV_Feb_2019.pdf Draft Buccal Tablet 022404 02/2019
Miconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Nitrate_vagcrm2_17450_RC10-09.pdf Draft Vaginal Cream 2% 017450 10/2009
Miconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Nitrate_vagcrm4 _20827_RC10-09.pdf Draft Vaginal Cream 4% 020827 10/2009
Miconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Nitrate_vagsupp100mg_18520_ RC10-09.pdf Draft Vaginal Suppository 100 mg 018520 10/2009
Miconazole Nitrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miconazole_Nitrate_vagsupp200mg_18888_ RC10-09.pdf Draft Vaginal Suppository 200 mg 018888 10/2009
Midazolam https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211321.pdf Draft Nasal Spray 211321 05/2021
Midodrine Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Midodrine_HCl_tab_19815_RC8-08.pdf Draft Oral Tablet 019815 08/2008
Midostaurin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Midostaurin_draft_Oral cap_RLD 207997_RC09-18.pdf Draft Oral Capsules 207997 09/2018
Mifepristone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202107.pdf Draft Oral Tablet 202107 11/2019
Mifepristone https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020687.pdf Draft Oral Tablet 020687 11/2019
Migalastat Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208623.pdf Draft Oral Capsule 208623 11/2019
Miglitol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miglitol_oral tablet_020682_RC06-15.pdf Draft Oral Tablet 020682 06/2015
Miglustat https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miglustat_cap_21348_RC5-06.pdf Final Oral Capsule 021348 05/2008
Milnacipran Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Milnacipran_HCl_tab_22256_RV09-11.pdf Draft Oral Tablet 022256 09/2011
Miltefosine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Miltefosine_draft_Oral cap_RLD 204684_RC09-18.pdf Draft Oral Capsules 204684 09/2018
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 03/2015
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minocycline_HCl_ERcap_201922_RC04-13.pdf Draft Oral Capsule, Extended Release 201922 04/2013
Minocycline Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minocyline HCl_oral tablet_NDA 50451_RV05-17.pdf Draft Oral Tablet 050451 07/2017
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 07/2017
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 09/2015
Minoxidil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minoxidil_fmaerosol_OTC_ 21812_RC5-10.pdf Draft Topical Aerosol, Foam 021812 02/2011
Minoxidil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minoxidil_sol_ 19501_OTC_RC5-10.pdf Draft Topical Solution 019501 05/2010
Minoxidil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minoxidil_sol_ 20834_OTC_RC5-10.pdf Draft Topical Solution 020834 05/2010
Minoxidil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Minoxidil_oral tablet_NDA 018154_RV05-17.pdf Draft Oral Tablet 018154 07/2017
Mirabegron https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mirabegron_ER_tab_202611_RC06-13.pdf Draft Oral Tablet, Extended Release 202611 06/2013
Mirtazapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mirtazapine_Oral Tablet_020415_RV03.pdf Draft Oral Tablet 020415 03/2015
Mirtazapine https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mirtazapine_ODtab_21208_RC5-05.pdf Final Oral Tablet, Orally Disintegrating 021208 05/2008
Misoprostol https://www.accessdata.fda.gov/drugsatfda_docs/psg/Misoprostol_tab_19268_RC2-10.pdf Draft Oral Tablet 019268 02/2010
Mitotane https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mitotane_Tabs_016885_RC04-13.pdf Draft Oral Tablet 016885 04/2013
Modafinil https://www.accessdata.fda.gov/drugsatfda_docs/psg/Modafinil_tab_20717_RC8-05.pdf Final Oral Tablet 020717 05/2008
Moexipril Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Moexipril_HCl_tab_20312_RC5-05.pdf Final Oral Tablet 020312 05/2008
Molindone Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017111.pdf Draft Oral Tablet 017111 11/2019
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone furoate_inhalation powder_NDA 021067_RC08-17.pdf Draft Inhalation Powder 021067 10/2017
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone furoate_Metered aerosol inhalation_RLD 205641_RC04-16.pdf Draft Inhalation Aerosol, Metered 205641 04/2016
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone furoate_topical cream_NDA 019625_RC04-16.pdf Draft Topical Cream 019625 04/2016
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone furoate_topical lotion_RLD 19796_RC04-16.pdf Draft Topical Lotion 019796 04/2016
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mometasone furoate_ topical ointment_RLD 019543_RC01-16.pdf Draft Topical Ointment 019543 01/2016
Mometasone Furoate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020762.pdf Draft Nasal Spray, Metered 020762 06/2020
Monomethyl Fumarate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210296.pdf Draft Oral Capsule, Delayed Release 210296 03/2021
Montelukast Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Montelukast_gran_21409_RC7-08.pdf Draft Oral Granules 021409 07/2008
Montelukast Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Montelukast_Sodium_tab_20829_RC8-08.pdf Draft Oral Tablet 020829 07/2008
Montelukast Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Montelukast_Sodium_chewtab_20830_RC12-05.pdf Draft Oral Tablet, Chewable 020830 07/2008
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 09/2018
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine sulfate_oral solution_RLD 022195_RC09-16.pdf Draft Oral Solution 022195 10/2016
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine_Sulfate_ERtab_19516_RC12-10.pdf Draft Oral Tablet, Extended Release 019516 12/2010
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine_Sulfate_tab_ 22207_RC2-10.pdf Draft Oral Tablet 022207 02/2010
Morphine Sulfate https://www.accessdata.fda.gov/drugsatfda_docs/psg/Morphine_Suflate_ERCap_21260_RC11-10.pdf Draft Oral Capsule, Extended Release 021260 11/2010
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 02/2018
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 09/2018
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 07/2018
Moxidectin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_210867.pdf Draft Oral Tablet 210867 03/2020
Moxifloxacin Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/Moxifloxacin_HCl_tab_21085_RC7-08.pdf Draft Oral Tablet 021085 07/2008
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 07/2018
Mupirocin https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mupirocin_oint_50591_RC06-10.pdf Draft Topical Ointment 050591 06/2010
Mupirocin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mupirocin_ Calcium_cr_50746_RC06-10.pdf Draft Topical Cream 050746 10/2011
Mupirocin Calcium https://www.accessdata.fda.gov/drugsatfda_docs/psg/Mupirocin_ Calcium_nasal_oint_50703_RC06-10.pdf Draft Nasal Ointment 050703 06/2010
Mycophenolate Mofetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050759.pdf Draft Oral Suspension 050759 11/2019
Mycophenolate Mofetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050722.pdf Draft Oral Capsule 050722 08/2020
Mycophenolate Mofetil https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_050723.pdf Draft Oral Tablet 050723 08/2020
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 11/2018

Newly Added Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Acyclovir https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_202408.pdf Draft Ophthalmic Ointment 202408 08/2021
Albuterol Sulfate; Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021747.pdf Draft Inhalation Spray, Metered 021747 08/2021
Amisulpride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209510.pdf Draft Intravenous Solution 209510 08/2021
Avapritinib https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212608.pdf Draft Oral Tablet 212608 08/2021
Carbinoxamine Maleate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_008915.pdf Draft Oral Tablet 008915 08/2021
Cefiderocol Sulfate Tosylate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209445.pdf Draft Intravenous Powder 209445 08/2021
Copper Dotatate Cu-64 https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213227.pdf Draft Intravenous Solution 213227 08/2021
Esomeprazole Magnesium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_214278.pdf Draft Oral Tablet, Orally Disintegrating, Delayed Release 214278 08/2021
Estradiol https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021166.pdf Draft Transdermal Gel, Metered 021166 08/2021
Ethinyl Estradiol; Levonorgestrel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_204017.pdf Draft Transdermal System 204017 08/2021
Fostemsavir Tromethamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212950.pdf Draft Oral Tablet, Extended Release 212950 08/2021
Indomethacin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017814.pdf Draft Rectal Suppository 017814 08/2021
Ipratropium Bromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020393.pdf Draft Nasal Spray, Metered 020393 020394 08/2021
Lasmiditan Succinate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211280.pdf Draft Oral Tablet 211280 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021343.pdf Draft Subcutaneous Powder 021343 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_208219.pdf Draft Ophthalmic Gel 208219 08/2021
Olodaterol Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_203108.pdf Draft Inhalation Spray, Metered 203108 08/2021
Osilodrostat Phosphate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_212801.pdf Draft Oral Tablet 212801 08/2021
Ozanimod Hydrochloride https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209899.pdf Draft Oral Capsule 209899 08/2021
Paliperidone Palmitate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207946.pdf Draft Intramuscular Suspension, Extended Release 207946 08/2021
Semaglutide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_213051.pdf Draft Oral Tablet 213051 08/2021
Sufentanil Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_209128.pdf Draft Sublingual Tablet 209128 08/2021
Tazemetostat Hydrobromide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_211723.pdf Draft Oral Tablet 211723 08/2021

Newly Revised Guidances since August 2021

Active Ingredient (link to Specific Guidance) URL Type Route Dosage Form RLD or RS Number Date Recommended
Bexarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021055.pdf Draft Oral Capsule 021055 08/2021
Budesonide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021324.pdf Draft Oral Capsule, Delayed Release 021324 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022291.pdf Draft Oral Tablet 022291 08/2021
Eltrombopag Olamine https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207027.pdf Draft Oral For Suspension 207027 08/2021
Ferric Citrate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205874.pdf Draft Oral Tablet 205874 08/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_205109.pdf Draft Oral Tablet, Chewable 205109 09/2021
Ferric Oxyhydroxide https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021135.pdf Draft Intravenous Injectable 021135 09/2021
Letrozole https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020726.pdf Draft Oral Tablet 020726 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_019732.pdf Draft Injection Injectable 019732 020011 020263 08/2021
Leuprolide Acetate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020517.pdf Draft Injection Injectable 020517 020708 08/2021
Liothyronine Sodium https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_010379.pdf Draft Oral Tablet 010379 08/2021
Loteprednol Etabonate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020583.pdf Draft Ophthalmic Suspension/Drops 020583 08/2021
Nystatin https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_060578.pdf Draft Topical Powder 065203 08/2021
Orlistat https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020766.pdf Draft Oral Capsule 020766 021887 08/2021
Paclitaxel https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021660.pdf Draft IV Infusion For Suspension 021660 08/2021
Podofilox https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_020529.pdf Draft Topical Gel 020529 08/2021
Sodium Zirconium Cyclosilicate https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_207078.pdf Draft Oral For Suspension 207078 08/2021
Tazarotene https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_021184-Cre-0.05P.pdf Draft Topical Cream 0.05% 021184 08/2021

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