Alprazolam

Treats generalized anxiety disorder (GAD). ANDA 203346, held by Aurobindo Pharma. Alprazolam.

As of Nov 15, 2026, ANDA 203346 (Alprazolam), held by Aurobindo Pharma, was first approved by FDA on Jul 31, 2015, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 31, 2015
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Alprazolam tablets are 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 5 submissions below

Date	Submission	Status	Documents
Jul 31, 2015	Original application	Approved	None posted

Products

4 strengths and forms


Alprazolam0.25MG · tablet;oral	Alprazolam	Rx
Alprazolam0.5MG · tablet;oral	Alprazolam	Rx
Alprazolam1MG · tablet;oral	Alprazolam	Rx
Alprazolam2MG · tablet;oral	Alprazolam	Rx

All 5 submissions, including labeling and manufacturing supplements


Aug 29, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Aug 29, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Aug 29, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Dec 31, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Jul 31, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203346
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