Depo-Provera

NDA 12541, held by Pfizer. Medroxyprogesterone Acetate.

As of Nov 13, 2026, NDA 12541 (Depo-Provera), held by Pfizer, was first approved by FDA on Sep 23, 1960, with 27 approved supplements and 0 published complete response letters.

First approved: Sep 23, 1960
Review: Standard
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Sep 23, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Depo-Provera100MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Medroxyprogesterone Acetate	DiscontinuedReference drug
Depo-Provera400MG/ML · injectable;injection	Medroxyprogesterone Acetate	DiscontinuedReference drug

All 28 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 3, 2017	Supplement 86Labeling · Standard review	Approved	Letter Label
Mar 15, 2017	Supplement 88Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 85Labeling · Standard review	Approved	Letter Label
Jun 10, 2016	Supplement 84Labeling · Standard review	Approved	Letter Label
Jun 11, 2015	Supplement 83Labeling · Standard review	Approved	Letter Label
Jun 9, 2014	Supplement 82Manufacturing · Standard review	Approved	None posted
Nov 20, 2012	Supplement 78Manufacturing · Standard review	Approved	None posted
Apr 3, 2000	Supplement 69Manufacturing · Standard review	Approved	None posted
Nov 28, 1997	Supplement 67Labeling · Standard review	Approved	None posted
Nov 28, 1995	Supplement 66Manufacturing · Standard review	Approved	None posted
Sep 7, 1995	Supplement 57Labeling	Approved	None posted
Apr 18, 1995	Supplement 65Manufacturing · Standard review	Approved	None posted
Apr 12, 1995	Supplement 64Manufacturing · Standard review	Approved	None posted
Jul 27, 1994	Supplement 63Manufacturing · Standard review	Approved	None posted
Jun 16, 1994	Supplement 62Manufacturing · Standard review	Approved	None posted
Feb 18, 1994	Supplement 60Labeling · Standard review	Approved	None posted
Feb 17, 1994	Supplement 61Manufacturing · Standard review	Approved	None posted
Jun 23, 1993	Supplement 58Manufacturing · Standard review	Approved	None posted
Feb 20, 1990	Supplement 56Labeling	Approved	None posted
May 20, 1980	Supplement 49Manufacturing · Standard review	Approved	None posted
Jul 13, 1979	Supplement 48Labeling	Approved	None posted
Jan 19, 1979	Supplement 37Manufacturing · Standard review	Approved	None posted
Dec 4, 1978	Supplement 42Labeling	Approved	None posted
Nov 1, 1976	Supplement 41Manufacturing · Standard review	Approved	None posted
Nov 1, 1976	Supplement 39Manufacturing · Standard review	Approved	None posted
Nov 1, 1976	Supplement 38Labeling	Approved	None posted
Jan 16, 1976	Supplement 36Labeling	Approved	None posted
Sep 23, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 12541
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