Diazepam

Manages anxiety disorders. ANDA 70311, held by Hikma. Diazepam.

As of Nov 14, 2026, ANDA 70311 (Diazepam), held by Hikma, was first approved by FDA on Dec 16, 1985, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 16, 1985
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indications and Usage Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient’s recall of the procedures (see WARNINGS ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Dec 16, 1985	Original application	Approved	None posted

Products

3 strengths and forms


Diazepam50MG/10ML (5MG/ML) · injectable;injection	Diazepam	Rx
Diazepam5MG/ML (5MG/ML) · injectable;injection	Diazepam	Discontinued
Diazepam10MG/2ML (5MG/ML) · injectable;injection	Diazepam	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Jun 1, 2026	Supplement 28Manufacturing	Approved	None posted
Dec 16, 2024	Supplement 25Labeling · Standard review	Approved	None posted
Jan 17, 2023	Supplement 24Labeling · Standard review	Approved	None posted
Nov 12, 2021	Supplement 22Labeling · Standard review	Approved	Label
May 17, 2021	Supplement 21Labeling · Standard review	Approved	None posted
Feb 8, 2021	Supplement 20Labeling · Standard review	Approved	None posted
Feb 5, 2021	Supplement 18Labeling · Standard review	Approved	None posted
Feb 5, 2021	Supplement 19Labeling · Standard review	Approved	None posted
Apr 21, 2000	Supplement 15Manufacturing	Approved	None posted
Nov 16, 1998	Supplement 14Manufacturing	Approved	None posted
Mar 17, 1998	Supplement 13Manufacturing	Approved	None posted
Jul 8, 1997	Supplement 12Manufacturing	Approved	None posted
Nov 18, 1993	Supplement 11Manufacturing	Approved	None posted
Jun 22, 1993	Supplement 9Labeling	Approved	None posted
Feb 1, 1993	Supplement 8Labeling	Approved	None posted
Sep 7, 1988	Supplement 6Labeling	Approved	None posted
Feb 26, 1988	Supplement 5Labeling	Approved	None posted
Nov 3, 1986	Supplement 2Manufacturing	Approved	None posted
Dec 16, 1985	Original application	Approved	None posted

Identifiers

Application: ANDA 70311
Drugs@FDA: Overview at FDA
Company: Hikma

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