Medroxyprogesterone Acetate

ANDA 88484, held by Upsher Smith Labs. Medroxyprogesterone Acetate.

As of Nov 15, 2026, ANDA 88484 (Medroxyprogesterone Acetate), held by Upsher Smith Labs, was first approved by FDA on Jul 26, 1984, with 28 approved supplements and 0 published complete response letters.

First approved: Jul 26, 1984
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Jul 26, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Medroxyprogesterone Acetate10MG · tablet;oral	Medroxyprogesterone Acetate	Discontinued

All 29 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 33Manufacturing	Approved	None posted
Oct 18, 1995	Supplement 31Manufacturing	Approved	None posted
Sep 11, 1995	Supplement 32Manufacturing	Approved	None posted
Mar 28, 1995	Supplement 30Labeling	Approved	None posted
Sep 10, 1992	Supplement 29Labeling	Approved	None posted
Jun 19, 1992	Supplement 28Labeling	Approved	None posted
Mar 15, 1991	Supplement 34Labeling	Approved	None posted
Mar 15, 1991	Supplement 27Labeling	Approved	None posted
Aug 4, 1989	Supplement 25Labeling	Approved	None posted
Jun 27, 1989	Supplement 24Labeling	Approved	None posted
Mar 15, 1989	Supplement 23Labeling	Approved	None posted
Jun 16, 1988	Supplement 22Manufacturing	Approved	None posted
Apr 6, 1988	Supplement 21Manufacturing	Approved	None posted
Apr 6, 1988	Supplement 20Manufacturing	Approved	None posted
Apr 6, 1988	Supplement 19Manufacturing	Approved	None posted
Jul 9, 1986	Supplement 16Manufacturing	Approved	None posted
Mar 20, 1986	Supplement 14Manufacturing	Approved	None posted
Oct 16, 1985	Supplement 13Manufacturing	Approved	None posted
Aug 14, 1985	Supplement 10Manufacturing	Approved	None posted
Aug 14, 1985	Supplement 9Manufacturing	Approved	None posted
Aug 14, 1985	Supplement 6Manufacturing	Approved	None posted
Aug 14, 1985	Supplement 5Manufacturing	Approved	None posted
Aug 14, 1985	Supplement 1Manufacturing	Approved	None posted
Jun 14, 1985	Supplement 12Manufacturing	Approved	None posted
Feb 27, 1985	Supplement 8Manufacturing	Approved	None posted
Feb 27, 1985	Supplement 4Manufacturing	Approved	None posted
Feb 27, 1985	Supplement 3Manufacturing	Approved	None posted
Feb 27, 1985	Supplement 2Manufacturing	Approved	None posted
Jul 26, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88484
Drugs@FDA: Overview at FDA
Company: Upsher-Smith Laboratories

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