Ativan

Manages anxiety disorders. NDA 17794, held by Bausch. Lorazepam.

As of Nov 14, 2026, NDA 17794 (Ativan), held by Bausch, was first approved by FDA on Sep 30, 1977, with 28 approved supplements and 0 published complete response letters.

First approved: Sep 30, 1977
Review: Standard
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Ativan (lorazepam) is 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 Ativan (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 29 submissions below

Date	Submission	Status	Documents
Sep 30, 1977	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Ativan0.5MG · tablet;oral	Lorazepam	RxReference drug
Ativan1MG · tablet;oral	Lorazepam	RxReference drug
Ativan2MG · tablet;oral	Lorazepam	RxReference drug

All 29 submissions, including labeling and manufacturing supplements


Jan 13, 2023	Supplement 49Labeling · Standard review	Approved	Letter Label Medication Guide
Feb 5, 2021	Supplement 48Labeling	Approved	Label Medication Guide Letter
Dec 16, 2016	Supplement 44Labeling	Approved	Letter Label
Apr 18, 2007	Supplement 35Labeling · Standard review	Approved	Letter Label
Apr 20, 1988	Supplement 31Manufacturing · Standard review	Approved	None posted
Aug 4, 1987	Supplement 29Manufacturing · Standard review	Approved	None posted
Jul 30, 1987	Supplement 28Manufacturing · Standard review	Approved	None posted
Jun 15, 1987	Supplement 26Manufacturing · Standard review	Approved	None posted
Feb 2, 1987	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 15, 1986	Supplement 22Labeling	Approved	None posted
Oct 30, 1986	Supplement 23Manufacturing · Standard review	Approved	None posted
Oct 29, 1986	Supplement 24Manufacturing · Standard review	Approved	None posted
Apr 4, 1985	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 26, 1984	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 24, 1984	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 2, 1984	Supplement 18Labeling	Approved	None posted
Sep 29, 1983	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 29, 1983	Supplement 16Labeling	Approved	None posted
Oct 21, 1982	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 10, 1982	Supplement 11Manufacturing · Standard review	Approved	None posted
May 3, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 26, 1982	Supplement 10Labeling	Approved	None posted
Dec 18, 1980	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 16, 1980	Supplement 7Manufacturing · Standard review	Approved	None posted
Sep 2, 1980	Supplement 5Labeling	Approved	None posted
Sep 2, 1980	Supplement 6Labeling	Approved	None posted
Jan 24, 1979	Supplement 4Labeling	Approved	None posted
Sep 20, 1978	Supplement 3Labeling	Approved	None posted
Sep 30, 1977	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17794
Drugs@FDA: Overview at FDA
Company: Bausch Health

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