Product Details for NDA 021434
XANAX XR (ALPRAZOLAM)
0.5MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
2MG
Marketing Status: Prescription
3MG
Marketing Status: Prescription
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)
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
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)
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
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)
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
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
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