Winstrol

NDA 12885, held by Lundbeck Inc. Stanozolol.

As of Nov 13, 2026, NDA 12885 (Winstrol), held by Lundbeck Inc, was first approved by FDA on Jan 9, 1962, with 9 approved supplements and 0 published complete response letters.

First approved: Jan 9, 1962
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
May 14, 1984	Supplement 25Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 9, 1962	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Winstrol2MG · tablet;oral	Stanozolol	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 17, 2003	Supplement 37Labeling · Standard review	Approved	Letter
Apr 7, 1994	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 27, 1992	Supplement 36Labeling · Standard review	Approved	None posted
Dec 13, 1991	Supplement 35Labeling · Standard review	Approved	None posted
May 18, 1988	Supplement 33Labeling · Standard review	Approved	None posted
Mar 10, 1987	Supplement 31Manufacturing · Standard review	Approved	None posted
Feb 24, 1987	Supplement 32Labeling · Standard review	Approved	None posted
May 7, 1986	Supplement 30Labeling · Standard review	Approved	None posted
May 14, 1984	Supplement 25Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 9, 1962	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12885
Drugs@FDA: Overview at FDA
Company: Lundbeck

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