Product Details for ANDA 078449
ALPRAZOLAM (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: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078449
Product Number: 001
Approval Date: Nov 12, 2008
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
ALPRAZOLAM (ALPRAZOLAM)
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078449
Product Number: 001
Approval Date: Nov 12, 2008
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
1MG
Marketing Status: Prescription
Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078449
Product Number: 004
Approval Date: Dec 23, 2015
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
ALPRAZOLAM (ALPRAZOLAM)
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078449
Product Number: 004
Approval Date: Dec 23, 2015
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
2MG
Marketing Status: Prescription
Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078449
Product Number: 002
Approval Date: Nov 12, 2008
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
ALPRAZOLAM (ALPRAZOLAM)
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078449
Product Number: 002
Approval Date: Nov 12, 2008
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
3MG
Marketing Status: Prescription
Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078449
Product Number: 003
Approval Date: Nov 12, 2008
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078449
Product Number: 003
Approval Date: Nov 12, 2008
Applicant Holder Full Name: APOTEX INC
Marketing Status: Prescription
Patent and Exclusivity Information