Xanax Xr

Treats panic disorder with or without agoraphobia. NDA 21434, held by Upjohn. Alprazolam.

As of Nov 15, 2026, NDA 21434 (Xanax Xr), held by Upjohn, was first approved by FDA on Jan 17, 2003, with 9 approved supplements and 0 published complete response letters.

First approved: Jan 17, 2003
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Alprazolam XR is 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 10 submissions below

Date	Submission	Status	Documents
Jan 17, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


Xanax Xr0.5MG · tablet, extended release;oral	Alprazolam	RxReference drug
Xanax Xr1MG · tablet, extended release;oral	Alprazolam	RxReference drug
Xanax Xr2MG · tablet, extended release;oral	Alprazolam	RxReference drug
Xanax Xr3MG · tablet, extended release;oral	Alprazolam	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Jan 13, 2023	Supplement 22Labeling · Standard review	Approved	Label Medication Guide Letter
Mar 1, 2021	Supplement 18Labeling · Standard review	Approved	Letter Label
Feb 5, 2021	Supplement 21Labeling	Approved	Label Medication Guide Letter
Dec 16, 2016	Supplement 16Labeling	Approved	Letter Label
Apr 7, 2016	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 4, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 23, 2011	Supplement 7Labeling	Approved	Letter Label
Jun 1, 2011	Supplement 6Labeling	Approved	Label Letter
Apr 2, 2004	Supplement 1Labeling · Standard review	Approved	Review Letter
Jan 17, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21434
Drugs@FDA: Overview at FDA
Company: Upjohn

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