Halotestin

NDA 10611, held by Pharmacia And Upjohn. Fluoxymesterone.

As of Nov 13, 2026, NDA 10611 (Halotestin), held by Pharmacia And Upjohn, was first approved by FDA on Oct 15, 1956, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 15, 1956
Review: Priority
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Oct 15, 1956	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

3 strengths and forms


Halotestin2MG · tablet;oral	Fluoxymesterone	Discontinued
Halotestin5MG · tablet;oral	Fluoxymesterone	Discontinued
Halotestin10MG · tablet;oral	Fluoxymesterone	Discontinued

All 9 submissions, including labeling and manufacturing supplements


May 20, 1991	Supplement 37Labeling	Approved	None posted
May 20, 1991	Supplement 38Labeling	Approved	None posted
Nov 2, 1990	Supplement 36Labeling	Approved	None posted
May 5, 1989	Supplement 34Manufacturing · Priority review	Approved	None posted
May 5, 1989	Supplement 35Manufacturing · Priority review	Approved	None posted
Mar 5, 1987	Supplement 33Labeling	Approved	None posted
Jun 18, 1984	Supplement 32Labeling	Approved	None posted
Jun 14, 1978	Supplement 21Labeling	Approved	None posted
Oct 15, 1956	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 10611
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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