Lorazepam

Manages anxiety disorders. ANDA 72927, held by Watson Labs. Lorazepam.

As of Nov 13, 2026, ANDA 72927 (Lorazepam), held by Watson Labs, was first approved by FDA on Oct 31, 1991, with 19 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1991
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Lorazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Oct 31, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lorazepam1MG · tablet;oral	Lorazepam	Rx

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 1, 2024	Supplement 46Labeling · Standard review	Approved	None posted
Mar 1, 2024	Supplement 45Labeling · Standard review	Approved	None posted
Apr 27, 2021	Supplement 42Labeling · Standard review	Approved	None posted
Apr 27, 2021	Supplement 40Labeling · Standard review	Approved	None posted
Sep 10, 2008	Supplement 31Labeling	Approved	None posted
Apr 12, 2001	Supplement 16Manufacturing	Approved	None posted
Mar 21, 2000	Supplement 15Manufacturing	Approved	None posted
Sep 2, 1999	Supplement 14Manufacturing	Approved	None posted
Sep 2, 1999	Supplement 13Manufacturing	Approved	None posted
Aug 21, 1998	Supplement 12Manufacturing	Approved	None posted
Jul 8, 1997	Supplement 10Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 8Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 7Manufacturing	Approved	None posted
Mar 18, 1996	Supplement 6Manufacturing	Approved	None posted
Feb 5, 1996	Supplement 5Manufacturing	Approved	None posted
Mar 2, 1995	Supplement 4Manufacturing	Approved	None posted
Jun 1, 1994	Supplement 3Manufacturing	Approved	None posted
Jun 1, 1994	Supplement 2Manufacturing	Approved	None posted
Jun 22, 1993	Supplement 1Labeling	Approved	None posted
Oct 31, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 72927
Drugs@FDA: Overview at FDA
Company: Watson 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