Diazepam

ANDA 70153, held by Teva Pharms. Diazepam.

As of Nov 13, 2026, ANDA 70153 (Diazepam), held by Teva Pharms, was first approved by FDA on Nov 1, 1985, with 19 approved supplements and 0 published complete response letters.

First approved: Nov 1, 1985
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Nov 1, 1985	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diazepam5MG · tablet;oral	Diazepam	Discontinued

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 29, 2003	Supplement 26Labeling	Approved	None posted
Oct 25, 2001	Supplement 25Manufacturing	Approved	None posted
Jan 29, 2001	Supplement 24Manufacturing	Approved	None posted
Dec 21, 1999	Supplement 23Manufacturing	Approved	None posted
May 20, 1999	Supplement 21Manufacturing	Approved	None posted
May 7, 1999	Supplement 22Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 19Manufacturing	Approved	None posted
Nov 5, 1998	Supplement 20Manufacturing	Approved	None posted
Aug 2, 1993	Supplement 18Labeling	Approved	None posted
Apr 3, 1992	Supplement 17Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 15Manufacturing	Approved	None posted
Jul 3, 1991	Supplement 14Labeling	Approved	None posted
Jul 3, 1991	Supplement 13Manufacturing	Approved	None posted
Oct 14, 1988	Supplement 12Labeling	Approved	None posted
Sep 8, 1988	Supplement 10Manufacturing	Approved	None posted
Sep 8, 1988	Supplement 9Manufacturing	Approved	None posted
Aug 14, 1987	Supplement 5Manufacturing	Approved	None posted
Apr 1, 1987	Supplement 7Manufacturing	Approved	None posted
Feb 5, 1986	Supplement 1Manufacturing	Approved	None posted
Nov 1, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70153
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters