Teslac

NDA 16118, held by Bristol Myers Squibb. Testolactone.

As of Nov 14, 2026, NDA 16118 (Teslac), held by Bristol Myers Squibb, was first approved by FDA on May 27, 1970, with 16 approved supplements and 0 published complete response letters.

First approved: May 27, 1970
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
May 27, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Teslac50MG · tablet;oral	Testolactone	Discontinued
Teslac250MG · tablet;oral	Testolactone	Discontinued

All 17 submissions, including labeling and manufacturing supplements


Mar 21, 2003	Supplement 23Labeling · Standard review	Approved	Letter Label
Mar 22, 2001	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 24, 1999	Supplement 20Labeling · Standard review	Approved	None posted
Feb 25, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 10, 1995	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 28, 1995	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 9, 1992	Supplement 18Labeling · Standard review	Approved	None posted
Aug 20, 1987	Supplement 14Labeling · Standard review	Approved	None posted
May 30, 1986	Supplement 16Manufacturing · Standard review	Approved	None posted
Jul 3, 1985	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 11, 1979	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 27, 1979	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 4, 1978	Supplement 11Manufacturing · Standard review	Approved	None posted
Jan 16, 1978	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 22, 1976	Supplement 9REMS · Standard review	Approved	None posted
May 6, 1976	Supplement 8Manufacturing · Standard review	Approved	None posted
May 27, 1970	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 16118
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