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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 021434

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NDA 021434 describes XANAX XR, which is a drug marketed by Upjohn and is included in one NDA. It is available from two suppliers. Additional details are available on the XANAX XR profile page.

The generic ingredient in XANAX XR is alprazolam. There are fifteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

Summary for 021434

Tradename:	XANAX XR
Applicant:	Upjohn
Ingredient:	alprazolam
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021434

Medical Subject Heading (MeSH) Categories for 021434

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 021434

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434	NDA	PHARMACIA & UPJOHN COMPANY LLC	0009-0057	0009-0057-07	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0009-0057-07)
XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434	NDA	PHARMACIA & UPJOHN COMPANY LLC	0009-0059	0009-0059-07	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0009-0059-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.5MG
Approval Date:	Jan 17, 2003	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1MG
Approval Date:	Jan 17, 2003	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	2MG
Approval Date:	Jan 17, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021434

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-003	Jan 17, 2003	⤷ Try a Trial	⤷ Try a Trial
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-004	Jan 17, 2003	⤷ Try a Trial	⤷ Try a Trial
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-001	Jan 17, 2003	⤷ Try a Trial	⤷ Try a Trial
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-002	Jan 17, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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