Tenuate

NDA 11722, held by Mpp Pharma. Diethylpropion Hydrochloride.

As of Nov 14, 2026, NDA 11722 (Tenuate), held by Mpp Pharma, was first approved by FDA on Aug 6, 1959, with 17 approved supplements and 0 published complete response letters.

First approved: Aug 6, 1959
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Aug 6, 1959	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tenuate25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Diethylpropion Hydrochloride	DiscontinuedReference drug

All 18 submissions, including labeling and manufacturing supplements


Sep 3, 2004	Supplement 29Labeling · Standard review	Approved	Letter Label
Jul 14, 2000	Supplement 28Manufacturing · Priority review	Approved	None posted
May 6, 1999	Supplement 27Labeling · Standard review	Approved	None posted
Feb 2, 1998	Supplement 25Labeling · Standard review	Approved	None posted
Jul 21, 1988	Supplement 24Manufacturing · Priority review	Approved	None posted
Jun 17, 1988	Supplement 17Labeling	Approved	None posted
Oct 3, 1986	Supplement 22Manufacturing · Priority review	Approved	None posted
Feb 10, 1984	Supplement 21Manufacturing · Priority review	Approved	None posted
Jan 6, 1984	Supplement 20Manufacturing · Priority review	Approved	None posted
Aug 3, 1983	Supplement 16Manufacturing · Priority review	Approved	None posted
Jun 8, 1983	Supplement 19Manufacturing · Priority review	Approved	None posted
Dec 6, 1982	Supplement 18Labeling	Approved	None posted
Oct 18, 1982	Supplement 15Manufacturing · Priority review	Approved	None posted
Oct 31, 1979	Supplement 14Manufacturing · Priority review	Approved	None posted
Apr 27, 1978	Supplement 13Manufacturing · Priority review	Approved	None posted
Sep 23, 1976	Supplement 11Manufacturing · Priority review	Approved	None posted
Feb 12, 1976	Supplement 10Manufacturing · Priority review	Approved	None posted
Aug 6, 1959	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 11722
Drugs@FDA: Overview at FDA
Company: MPP Pharma

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