Nandrolone Decanoate

ANDA 86385, held by Watson Labs. Nandrolone Decanoate.

As of Nov 15, 2026, ANDA 86385 (Nandrolone Decanoate), held by Watson Labs, was first approved by FDA on Jan 13, 1984, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 13, 1984
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nandrolone Decanoate50MG/ML · injectable;injection	Nandrolone Decanoate	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Feb 19, 1999	Supplement 28Manufacturing	Approved	None posted
Feb 2, 1999	Supplement 27Manufacturing	Approved	None posted
Dec 8, 1997	Supplement 26Manufacturing	Approved	None posted
Dec 4, 1996	Supplement 25Manufacturing	Approved	None posted
Jun 29, 1995	Supplement 24Manufacturing	Approved	None posted
Mar 4, 1993	Supplement 23Labeling	Approved	None posted
Feb 11, 1991	Supplement 22Labeling	Approved	None posted
Nov 21, 1989	Supplement 21Labeling	Approved	None posted
Jun 21, 1989	Supplement 17Labeling	Approved	None posted
Mar 8, 1989	Supplement 7Bioequivalence	Approved	None posted
Feb 1, 1989	Supplement 16Manufacturing	Approved	None posted
Feb 1, 1989	Supplement 15Manufacturing	Approved	None posted
Feb 1, 1989	Supplement 14Manufacturing	Approved	None posted
Jun 8, 1988	Supplement 12Labeling	Approved	None posted
May 2, 1986	Supplement 10Manufacturing	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 30, 1983	Supplement 3Manufacturing	Approved	None posted
Dec 30, 1983	Supplement 1Manufacturing	Approved	None posted
May 17, 1983	Supplement 4Manufacturing	Approved	None posted

Identifiers

Application: ANDA 86385
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