Details for New Drug Application (NDA): 021434

✉ Email this page to a colleague

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-four 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

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	Viatris Specialty LLC	58151-503	58151-503-91	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (58151-503-91)
XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434	NDA	Viatris Specialty LLC	58151-504	58151-504-91	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (58151-504-91)

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

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-001	Jan 17, 2003	⤷ Get Started Free	⤷ Get Started Free
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-004	Jan 17, 2003	⤷ Get Started Free	⤷ Get Started Free
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-003	Jan 17, 2003	⤷ Get Started Free	⤷ Get Started Free
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-002	Jan 17, 2003	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.