Diazepam

ANDA 72397, held by Watson Labs Inc. Diazepam.

As of Nov 13, 2026, ANDA 72397 (Diazepam), held by Watson Labs Inc, was first approved by FDA on Jan 29, 1993, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 29, 1993
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jan 29, 1993	Original application	Approved	None posted

Products

1 strengths and forms

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

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 16, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Aug 16, 1996	Supplement 2Manufacturing	Approved	None posted
Aug 16, 1996	Supplement 3Labeling	Approved	None posted
Aug 16, 1996	Supplement 4Manufacturing	Approved	None posted
Aug 16, 1996	Supplement 5Manufacturing	Approved	None posted
Mar 23, 1994	Supplement 1Manufacturing	Approved	None posted
Jan 29, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 72397
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