Diazepam

Manages anxiety disorders. ANDA 71307, held by Ivax Sub Teva Pharms. Diazepam.

As of Nov 14, 2026, ANDA 71307 (Diazepam), held by Ivax Sub Teva Pharms, was first approved by FDA on Dec 10, 1986, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 10, 1986
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS Diazepam tablets are 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 tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Dec 10, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diazepam2MG · tablet;oral	Diazepam	Rx

All 16 submissions, including labeling and manufacturing supplements


Mar 9, 2015	Supplement 31Labeling · Standard review	Approved	None posted
Jan 28, 2013	Supplement 29Labeling · Standard review	Approved	None posted
Jul 23, 2008	Supplement 24Labeling	Approved	None posted
Jul 29, 2002	Supplement 13Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 12Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 10Manufacturing	Approved	None posted
Mar 30, 1998	Supplement 9Manufacturing	Approved	None posted
Oct 30, 1996	Supplement 7Manufacturing	Approved	None posted
Oct 29, 1996	Supplement 8Manufacturing	Approved	None posted
Oct 22, 1993	Supplement 6Labeling	Approved	None posted
Jul 25, 1991	Supplement 5Manufacturing	Approved	None posted
Mar 14, 1990	Supplement 3Labeling	Approved	None posted
Mar 14, 1990	Supplement 4Labeling	Approved	None posted
Mar 25, 1987	Supplement 1Manufacturing	Approved	None posted
Mar 25, 1987	Supplement 2Manufacturing	Approved	None posted
Dec 10, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 71307
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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