Tepanil Ten-Tab

NDA 17956, held by 3m. Diethylpropion Hydrochloride.

As of Nov 14, 2026, NDA 17956 (Tepanil Ten-Tab), held by 3m, was first approved by FDA on May 25, 1977, with 25 approved supplements and 0 published complete response letters.

First approved: May 25, 1977
Review: Standard
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
May 25, 1977	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tepanil Ten-Tab75MG · tablet, extended release;oral	Diethylpropion Hydrochloride	Discontinued

All 26 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 20Labeling	Approved	None posted
Dec 7, 2007	Supplement 17Labeling	Approved	None posted
Mar 14, 1996	Supplement 25Manufacturing · Standard review	Approved	None posted
Nov 28, 1995	Supplement 26Manufacturing · Standard review	Approved	None posted
Jun 16, 1987	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 17, 1987	Supplement 23Labeling	Approved	None posted
Aug 26, 1985	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 26, 1985	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 1, 1981	Supplement 19Labeling	Approved	None posted
Jul 1, 1981	Supplement 18Labeling	Approved	None posted
Jul 1, 1981	Supplement 16Labeling	Approved	None posted
Jul 1, 1981	Supplement 15Labeling	Approved	None posted
Jul 1, 1981	Supplement 14Labeling	Approved	None posted
Jul 1, 1981	Supplement 13Labeling	Approved	None posted
Jul 1, 1981	Supplement 12Labeling	Approved	None posted
Jul 1, 1981	Supplement 11Labeling	Approved	None posted
Jul 1, 1981	Supplement 10Labeling	Approved	None posted
Jul 1, 1981	Supplement 9Labeling	Approved	None posted
Jul 1, 1981	Supplement 8Labeling	Approved	None posted
Jul 1, 1981	Supplement 7Labeling	Approved	None posted
Jul 1, 1981	Supplement 6Labeling	Approved	None posted
Feb 23, 1981	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 18, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
May 2, 1980	Supplement 2Labeling	Approved	None posted
Nov 17, 1978	Supplement 1Manufacturing · Standard review	Approved	None posted
May 25, 1977	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17956
Drugs@FDA: Overview at FDA
Company: 3M

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