Tenuate

NDA 17668, held by Sanofi Aventis US. Diethylpropion Hydrochloride.

As of Nov 13, 2026, NDA 17668 (Tenuate), held by Sanofi Aventis US, was first approved by FDA on Mar 20, 1975, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 20, 1975
Review: Standard
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Mar 20, 1975	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tenuate25MG · tablet;oral	Diethylpropion Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 7, 2007	Supplement 1Labeling	Approved	None posted
May 18, 1981	Supplement 10Labeling	Approved	None posted
May 27, 1980	Supplement 9Labeling	Approved	None posted
May 12, 1980	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 2, 1979	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 27, 1978	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 24, 1976	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 24, 1976	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 10, 1976	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 20, 1975	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17668
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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