Alprazolam

Treats generalized anxiety disorder (GAD). ANDA 74312, held by Hikma. Alprazolam.

As of Nov 15, 2026, ANDA 74312 (Alprazolam), held by Hikma, was first approved by FDA on Oct 31, 1993, with 10 approved supplements and 0 published complete response letters.

First approved: Oct 31, 1993
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Alprazolam is indicated for the:

acute treatment of generalized anxiety disorder (GAD) in adults.
treatment of panic disorder (PD), with or without agoraphobia in adults. Alprazolam is a benzodiazepine indicated for the:
Acute treatment of generalized anxiety disorder in adults.
Treatment of panic disorder with or without agoraphobia in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Oct 31, 1993	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Alprazolam1MG/ML · concentrate;oral	Alprazolam	Rx

All 11 submissions, including labeling and manufacturing supplements


Nov 18, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Jun 16, 2021	Supplement 16Manufacturing	Approved	None posted
Mar 31, 2017	Supplement 13Labeling	Approved	None posted
Nov 28, 2007	Supplement 11Labeling	Approved	None posted
Sep 5, 2001	Supplement 6Manufacturing	Approved	None posted
Jul 27, 2001	Supplement 5Manufacturing	Approved	None posted
Jun 21, 2001	Supplement 4Labeling	Approved	None posted
Aug 12, 1997	Supplement 3Labeling	Approved	None posted
Aug 28, 1996	Supplement 2Manufacturing	Approved	None posted
Jan 7, 1994	Supplement 1Labeling	Approved	None posted
Oct 31, 1993	Original application	Approved	Review

Identifiers

Application: ANDA 74312
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