Depo-Testadiol

NDA 17968, held by Pharmacia And Upjohn. Estradiol Cypionate; Testosterone Cypionate.

As of Nov 13, 2026, NDA 17968 (Depo-Testadiol), held by Pharmacia And Upjohn, was first approved by FDA on Jun 13, 1980, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1980
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 13, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Depo-Testadiol2MG/ML;50MG/ML · injectable;injection	Estradiol Cypionate; Testosterone Cypionate	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 23, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 3, 2000	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 22, 1996	Supplement 6Labeling · Standard review	Approved	None posted
Jul 15, 1994	Supplement 7Labeling · Standard review	Approved	None posted
May 10, 1993	Supplement 5Labeling · Standard review	Approved	None posted
Jun 28, 1985	Supplement 3Labeling · Standard review	Approved	None posted
Apr 15, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 13, 1980	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17968
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