Diazepam

ANDA 70781, held by Actavis Elizabeth. Diazepam.

As of Nov 13, 2026, ANDA 70781 (Diazepam), held by Actavis Elizabeth, was first approved by FDA on Sep 19, 1986, with 12 approved supplements and 0 published complete response letters.

First approved: Sep 19, 1986
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Sep 19, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diazepam2MG · tablet;oral	Diazepam	Discontinued

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 20, 2003	Supplement 13Labeling	Approved	None posted
Oct 11, 2002	Supplement 11Manufacturing	Approved	None posted
Nov 2, 2001	Supplement 10Manufacturing	Approved	None posted
Oct 25, 2000	Supplement 9Manufacturing	Approved	None posted
Oct 25, 2000	Supplement 8Manufacturing	Approved	None posted
Nov 4, 1999	Supplement 7Manufacturing	Approved	None posted
Jul 20, 1999	Supplement 6Manufacturing	Approved	None posted
Jan 18, 1996	Supplement 5Manufacturing	Approved	None posted
Mar 31, 1993	Supplement 4Labeling	Approved	None posted
Jun 7, 1988	Supplement 3Labeling	Approved	None posted
Jan 21, 1988	Supplement 2Manufacturing	Approved	None posted
Jan 21, 1988	Supplement 1Manufacturing	Approved	None posted
Sep 19, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70781
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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