Diazepam

ANDA 70296, held by Watson Labs. Diazepam.

As of Nov 13, 2026, ANDA 70296 (Diazepam), held by Watson Labs, was first approved by FDA on Feb 12, 1986, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 12, 1986
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Feb 12, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diazepam5MG/ML · injectable;injection	Diazepam	Discontinued

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 16, 2016	Supplement 20Labeling · Standard review	Approved	None posted
Feb 19, 1999	Supplement 18Manufacturing	Approved	None posted
Jan 25, 1999	Supplement 17Manufacturing	Approved	None posted
Mar 8, 1994	Supplement 15Labeling	Approved	None posted
Feb 21, 1991	Supplement 12Manufacturing	Approved	None posted
Jul 9, 1990	Supplement 14Labeling	Approved	None posted
Oct 18, 1989	Supplement 11Labeling	Approved	None posted
Jun 2, 1988	Supplement 8Manufacturing	Approved	None posted
Jun 2, 1988	Supplement 7Labeling	Approved	None posted
Oct 28, 1987	Supplement 3Manufacturing	Approved	None posted
Oct 28, 1987	Supplement 2Manufacturing	Approved	None posted
Mar 25, 1987	Supplement 5Manufacturing	Approved	None posted
Jun 12, 1986	Supplement 1Manufacturing	Approved	None posted
Feb 12, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70296
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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