← FDA DRUG APPROVALS

FDA NDA · NDA021434

XANAX XR

alprazolam

Sponsor: UPJOHN

APPLICATION
NDA021434
TYPE
NDA
ORIGINAL APPROVAL
2003-01-17
LATEST ACTION
2023-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

XANAX XR · ReferencePrescription
ALPRAZOLAM 2MG · TABLET, EXTENDED RELEASE · ORAL
XANAX XR · ReferencePrescription
ALPRAZOLAM 0.5MG · TABLET, EXTENDED RELEASE · ORAL
XANAX XR · ReferencePrescription
ALPRAZOLAM 3MG · TABLET, EXTENDED RELEASE · ORAL
XANAX XR · ReferencePrescription
ALPRAZOLAM 1MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-01-13Labeling · Supplement 22 · standard — Letter ↗AP
2021-03-01Labeling · Supplement 18 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 21 · 901 required — Letter ↗AP
2016-12-16Labeling · Supplement 16 · 901 required — Label ↗AP
2016-04-07Manufacturing (CMC) · Supplement 15 · standardAP
2013-12-04Manufacturing (CMC) · Supplement 13 · standardAP
2011-08-23Labeling · Supplement 7 · unknown — Letter ↗AP
2011-06-01Labeling · Supplement 6 · unknown — Letter ↗AP
2004-04-02Labeling · Supplement 1 · standard — Review ↗AP
2003-01-17Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →