Alprazolam

Treats panic disorder with or without agoraphobia. ANDA 90871, held by Aurobindo Pharma. Alprazolam.

As of Nov 15, 2026, ANDA 90871 (Alprazolam), held by Aurobindo Pharma, was first approved by FDA on Jun 7, 2011, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 7, 2011
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Alprazolam extended-release tablets are indicated for the 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 7 submissions below

Date	Submission	Status	Documents
Jun 7, 2011	Original application	Approved	None posted

Products

4 strengths and forms


Alprazolam0.5MG · tablet, extended release;oral	Alprazolam	Rx
Alprazolam1MG · tablet, extended release;oral	Alprazolam	Rx
Alprazolam2MG · tablet, extended release;oral	Alprazolam	Rx
Alprazolam3MG · tablet, extended release;oral	Alprazolam	Rx

All 7 submissions, including labeling and manufacturing supplements


Apr 11, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Apr 11, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Apr 11, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Apr 11, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Sep 19, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Aug 22, 2011	Supplement 1Labeling	Approved	None posted
Jun 7, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90871
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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