Anadrol-50

NDA 16848, held by Pharmobedient. Oxymetholone.

As of Nov 13, 2026, NDA 16848 (Anadrol-50), held by Pharmobedient, was first approved by FDA on Jan 18, 1972, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 18, 1972
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jan 18, 1972	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Anadrol-5050MG · tablet;oral	Oxymetholone	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 6, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 25, 2004	Supplement 21Labeling · Standard review	Approved	Letter Label
Nov 17, 2003	Supplement 20Labeling · Standard review	Approved	Letter
Feb 6, 2002	Supplement 19Manufacturing · Standard review	Approved	None posted
May 14, 1997	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 9, 1994	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 15, 1993	Supplement 16Labeling	Approved	None posted
Jul 15, 1993	Supplement 13Labeling	Approved	None posted
Aug 24, 1992	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 18, 1992	Supplement 15Labeling	Approved	None posted
Aug 14, 1991	Supplement 12Labeling	Approved	None posted
Jan 26, 1990	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 25, 1986	Supplement 10Labeling	Approved	None posted
Jan 18, 1983	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 15, 1980	Supplement 6Labeling	Approved	None posted
Jun 15, 1976	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 10, 1975	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 18, 1972	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16848
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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