Teslac

NDA 16119, held by Bristol Myers Squibb. Testolactone.

As of Nov 13, 2026, NDA 16119 (Teslac), held by Bristol Myers Squibb, was first approved by FDA on Jun 3, 1969, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 3, 1969
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jun 3, 1969	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Teslac100MG/ML · injectable;injection	Testolactone	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Oct 11, 1979	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 27, 1979	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 1, 1978	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 16, 1978	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 22, 1977	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 6, 1976	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 3, 1969	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 16119
Drugs@FDA: Overview at FDA
Company: Bristol-Myers Squibb

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