Alprazolam

Treats panic disorder with or without agoraphobia. ANDA 78387, held by Amneal Pharms Ny. Alprazolam.

As of Nov 15, 2026, ANDA 78387 (Alprazolam), held by Amneal Pharms Ny, was first approved by FDA on May 30, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: May 30, 2008
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
May 30, 2008	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 5 submissions, including labeling and manufacturing supplements


Mar 15, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Mar 15, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Mar 15, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Mar 15, 2024	Supplement 10Labeling · Standard review	Approved	None posted
May 30, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78387
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals of New York

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