Depo-Subq Provera 104

Prevents pregnancy. NDA 21583, held by Pfizer. Medroxyprogesterone Acetate.

As of Nov 14, 2026, NDA 21583 (Depo-Subq Provera 104), held by Pfizer, was first approved by FDA on Dec 17, 2004, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 17, 2004
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Depo-subQ provera 104 is indicated in females of reproductive age for:

Prevention of pregnancy
Management of endometriosis-associated pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below


Dec 4, 2020	Supplement 34Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 4, 2020	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 17, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Depo-Subq Provera 104104MG/0.65ML · injectable;subcutaneous	Medroxyprogesterone Acetate	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Dec 12, 2025	Supplement 45Labeling · Standard review	Approved	Label Letter
Dec 16, 2024	Supplement 43Labeling · Standard review	Approved	Letter Label
Jul 11, 2024	Supplement 40Labeling · Standard review	Approved	Letter Label
Dec 4, 2020	Supplement 34Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 4, 2020	Supplement 33Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 23, 2019	Supplement 29Labeling · Standard review	Approved	Label Letter
Dec 23, 2019	Supplement 24Labeling · Standard review	Approved	Label Letter
Dec 23, 2019	Supplement 16Labeling	Approved	Label Letter
Mar 1, 2018	Supplement 17Labeling	Approved	Letter
Jan 31, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Dec 16, 2016	Supplement 31Labeling · Standard review	Approved	Letter Label
Oct 14, 2016	Supplement 32Labeling · Standard review	Approved	Letter Label
Aug 4, 2016	Supplement 27Manufacturing · Standard review	Approved	None posted
Feb 29, 2016	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 30, 2015	Supplement 25Labeling · Standard review	Approved	Label Letter
Jan 23, 2015	Supplement 26Labeling · Standard review	Approved	Label Letter
Jul 15, 2009	Supplement 11Manufacturing	Approved	Letter Label
Oct 5, 2007	Supplement 6Labeling · Standard review	Approved	Letter Label
Nov 8, 2005	Supplement 3Labeling · Standard review	Approved	Letter Label
May 2, 2005	Supplement 1Labeling · Standard review	Approved	Letter
Dec 17, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21583
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