Diazepam

ANDA 71135, held by Dr Reddys Labs SA. Diazepam.

As of Nov 14, 2026, ANDA 71135 (Diazepam), held by Dr Reddys Labs SA, was first approved by FDA on Feb 3, 1987, with 14 approved supplements and 0 published complete response letters.

First approved: Feb 3, 1987
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Feb 3, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diazepam5MG · tablet;oral	Diazepam	Rx

All 15 submissions, including labeling and manufacturing supplements


Aug 2, 2021	Supplement 38Labeling · Standard review	Approved	None posted
Aug 2, 2021	Supplement 35Labeling · Standard review	Approved	None posted
Mar 9, 2015	Supplement 31Labeling · Standard review	Approved	None posted
Aug 6, 2008	Supplement 24Labeling	Approved	None posted
Jun 21, 2001	Supplement 13Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 14Manufacturing	Approved	None posted
Oct 17, 1997	Supplement 11Manufacturing	Approved	None posted
Jul 2, 1993	Supplement 41Labeling	Approved	None posted
Jul 2, 1993	Supplement 10Labeling	Approved	None posted
May 31, 1991	Supplement 9Manufacturing	Approved	None posted
Jul 10, 1990	Supplement 6Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 8Manufacturing	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 71135
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