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Last Updated: July 6, 2020

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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-nine 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
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 and 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 and 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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.5MG
Approval Date:Jan 17, 2003TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1MG
Approval Date:Jan 17, 2003TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Jan 17, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021434

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

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Serving leading biopharmaceutical companies globally:

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