Nandrolone Decanoate

ANDA 86598, held by Watson Labs. Nandrolone Decanoate.

As of Nov 15, 2026, ANDA 86598 (Nandrolone Decanoate), held by Watson Labs, was first approved by FDA on Jan 13, 1984, with 21 approved supplements and 0 published complete response letters.

First approved: Jan 13, 1984
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Jan 13, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nandrolone Decanoate100MG/ML · injectable;injection	Nandrolone Decanoate	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Jun 17, 2002	Supplement 27Manufacturing	Approved	None posted
Jun 17, 2002	Supplement 26Manufacturing	Approved	None posted
Jun 17, 2002	Supplement 25Manufacturing	Approved	None posted
Feb 19, 1999	Supplement 23Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 22Manufacturing	Approved	None posted
Dec 8, 1997	Supplement 21Manufacturing	Approved	None posted
Jun 29, 1995	Supplement 20Manufacturing	Approved	None posted
Feb 11, 1991	Supplement 18Labeling	Approved	None posted
Nov 21, 1989	Supplement 17Labeling	Approved	None posted
Jul 19, 1989	Supplement 15Manufacturing	Approved	None posted
Jun 21, 1989	Supplement 16Labeling	Approved	None posted
Sep 23, 1988	Supplement 12Bioequivalence	Approved	None posted
Aug 2, 1988	Supplement 14Manufacturing	Approved	None posted
Aug 2, 1988	Supplement 13Manufacturing	Approved	None posted
Jun 8, 1988	Supplement 11Labeling	Approved	None posted
May 2, 1986	Supplement 9Manufacturing	Approved	None posted
Jun 7, 1984	Supplement 8Manufacturing	Approved	None posted
Jan 13, 1984	Supplement 6Manufacturing	Approved	None posted
Jan 13, 1984	Original application	Approved	None posted
Dec 29, 1983	Supplement 2Manufacturing	Approved	None posted
Dec 29, 1983	Supplement 1Manufacturing	Approved	None posted
May 17, 1983	Supplement 5Manufacturing	Approved	None posted

Identifiers

Application: ANDA 86598
Drugs@FDA: Overview at FDA
Company: Watson 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