Diazepam

ANDA 71134, held by Dr Reddys Labs SA. Diazepam.

As of Nov 13, 2026, ANDA 71134 (Diazepam), held by Dr Reddys Labs SA, was first approved by FDA on Feb 3, 1987, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 3, 1987
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 3, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diazepam2MG · tablet;oral	Diazepam	Rx

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 2, 2021	Supplement 35Labeling · Standard review	Approved	None posted
Aug 2, 2021	Supplement 32Labeling · Standard review	Approved	None posted
Mar 9, 2015	Supplement 28Labeling · Standard review	Approved	None posted
Aug 6, 2008	Supplement 21Labeling	Approved	None posted
Jun 21, 2001	Supplement 12Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 13Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 10Labeling	Approved	None posted
May 31, 1991	Supplement 8Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 9Manufacturing	Approved	None posted
Sep 7, 1988	Supplement 6Manufacturing	Approved	None posted
Sep 7, 1988	Supplement 5Manufacturing	Approved	None posted
Aug 11, 1988	Supplement 2Manufacturing	Approved	None posted
May 4, 1988	Supplement 4Labeling	Approved	None posted
Feb 3, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 71134
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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