Medroxyprogesterone Acetate

ANDA 76552, held by Teva Pharms USA. Medroxyprogesterone Acetate.

As of Nov 15, 2026, ANDA 76552 (Medroxyprogesterone Acetate), held by Teva Pharms USA, was first approved by FDA on Oct 27, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 27, 2004
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 27, 2004	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Nov 29, 2011	Supplement 13Labeling	Approved	None posted
Mar 4, 2005	Supplement 1Labeling	Approved	None posted
Oct 27, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76552
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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