Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021434

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XANAX XR (ALPRAZOLAM)
0.5MG
Marketing Status: Prescription

Active Ingredient: ALPRAZOLAM
Proprietary Name: XANAX XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021434
Product Number: 001
Approval Date: Jan 17, 2003
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

XANAX XR (ALPRAZOLAM)
1MG
Marketing Status: Prescription

Active Ingredient: ALPRAZOLAM
Proprietary Name: XANAX XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021434
Product Number: 002
Approval Date: Jan 17, 2003
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

XANAX XR (ALPRAZOLAM)
2MG
Marketing Status: Prescription

Active Ingredient: ALPRAZOLAM
Proprietary Name: XANAX XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021434
Product Number: 003
Approval Date: Jan 17, 2003
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

XANAX XR (ALPRAZOLAM)
3MG
Marketing Status: Prescription

Active Ingredient: ALPRAZOLAM
Proprietary Name: XANAX XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021434
Product Number: 004
Approval Date: Jan 17, 2003
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status:  Prescription
Patent and Exclusivity Information