Medroxyprogesterone Acetate

ANDA 76553, held by Emerge Bioscience. Medroxyprogesterone Acetate.

As of Nov 15, 2026, ANDA 76553 (Medroxyprogesterone Acetate), held by Emerge Bioscience, was first approved by FDA on Jul 28, 2004, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 28, 2004
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jul 28, 2004	Original application	Approved	Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Medroxyprogesterone Acetate150MG/ML · injectable;injection	Medroxyprogesterone Acetate	Rx

All 7 submissions, including labeling and manufacturing supplements


Dec 8, 2021	Supplement 22Labeling · Standard review	Approved	None posted
Dec 8, 2021	Supplement 23Labeling · Standard review	Approved	None posted
Dec 8, 2021	Supplement 30Labeling · Standard review	Approved	None posted
Dec 8, 2021	Supplement 31Labeling · Standard review	Approved	None posted
Nov 30, 2011	Supplement 15Labeling	Approved	None posted
Mar 4, 2005	Supplement 2Labeling	Approved	None posted
Jul 28, 2004	Original application	Approved	Review Letter

Identifiers

Application: ANDA 76553
Drugs@FDA: Overview at FDA
Company: Emerge Bioscience

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