Depo-Provera

NDA 20246, held by Pfizer. Medroxyprogesterone Acetate.

As of Nov 13, 2026, NDA 20246 (Depo-Provera), held by Pfizer, was first approved by FDA on Oct 29, 1992, with 33 approved supplements and 0 published complete response letters.

First approved: Oct 29, 1992
Review: Priority
Supplements approved: 33
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Depo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below

Date	Submission	Status	Documents
Dec 4, 2020	Supplement 62Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 4, 2020	Supplement 60Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 28, 2011	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 15, 2010	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 29, 1992	Original applicationNew formulation or manufacturer · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Depo-Provera150MG/ML · injectable;injection	Medroxyprogesterone Acetate	RxReference drug

All 34 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 12, 2025	Supplement 74Labeling · Standard review	Approved	Label Letter
Jul 11, 2024	Supplement 68Labeling · Standard review	Approved	Letter Label
Dec 4, 2020	Supplement 62Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 4, 2020	Supplement 60Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 9, 2020	Supplement 57Labeling · Standard review	Approved	Label Letter
Sep 9, 2020	Supplement 43Labeling	Approved	Letter Label
Mar 16, 2017	Supplement 63Labeling · Standard review	Approved	Review Letter
Dec 16, 2016	Supplement 58Labeling · Standard review	Approved	Letter Label
Feb 24, 2016	Supplement 40Manufacturing · Priority review	Approved	None posted
Jan 30, 2015	Supplement 53Labeling · Standard review	Approved	Label Letter
Jan 23, 2015	Supplement 54Labeling · Standard review	Approved	Label Letter
Jun 9, 2014	Supplement 52Manufacturing · Priority review	Approved	Review
Sep 27, 2013	Supplement 50Manufacturing · Priority review	Approved	Review
Sep 10, 2013	Supplement 49Manufacturing · Priority review	Approved	Review
Mar 25, 2013	Supplement 48Manufacturing · Priority review	Approved	Review
Jul 28, 2011	Supplement 35Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 15, 2010	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 28, 2005	Supplement 13Labeling · Standard review	Approved	Label Letter
Nov 17, 2004	Supplement 25Labeling · Standard review	Approved	Review Label Letter
May 23, 2003	Supplement 19Manufacturing · Priority review	Approved	Letter Label
May 23, 2002	Supplement 18Manufacturing · Priority review	Approved	None posted
Apr 26, 2002	Supplement 17Manufacturing · Priority review	Approved	None posted
Jun 7, 2001	Supplement 15Manufacturing · Priority review	Approved	None posted
Apr 3, 2000	Supplement 14Manufacturing · Priority review	Approved	None posted
Aug 12, 1998	Supplement 12Labeling · Standard review	Approved	None posted
Jan 31, 1997	Supplement 11Labeling · Standard review	Approved	None posted
Mar 20, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Feb 1, 1996	Supplement 6Manufacturing · Priority review	Approved	None posted
Nov 28, 1995	Supplement 8Manufacturing · Priority review	Approved	None posted
May 3, 1995	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 1, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Dec 1, 1994	Supplement 3Labeling · Standard review	Approved	None posted
Feb 17, 1994	Supplement 2Manufacturing · Priority review	Approved	None posted
Oct 29, 1992	Original applicationNew formulation or manufacturer · Priority review	Approved	None posted

Identifiers

Application: NDA 20246
Drugs@FDA: Overview at FDA
Company: Pfizer

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters