Product Details for ANDA 074174
ALPRAZOLAM (ALPRAZOLAM)
0.25MG
Marketing Status: Prescription
0.5MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
2MG
Marketing Status: Prescription
0.25MG
Marketing Status: Prescription
Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074174
Product Number: 001
Approval Date: Oct 19, 1993
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ALPRAZOLAM (ALPRAZOLAM)
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074174
Product Number: 001
Approval Date: Oct 19, 1993
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
0.5MG
Marketing Status: Prescription
Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074174
Product Number: 002
Approval Date: Oct 19, 1993
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ALPRAZOLAM (ALPRAZOLAM)
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074174
Product Number: 002
Approval Date: Oct 19, 1993
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
1MG
Marketing Status: Prescription
Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074174
Product Number: 003
Approval Date: Oct 19, 1993
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ALPRAZOLAM (ALPRAZOLAM)
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074174
Product Number: 003
Approval Date: Oct 19, 1993
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
2MG
Marketing Status: Prescription
Active Ingredient: ALPRAZOLAM
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074174
Product Number: 004
Approval Date: Oct 19, 1993
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ALPRAZOLAM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A074174
Product Number: 004
Approval Date: Oct 19, 1993
Applicant Holder Full Name: NOVITIUM PHARMA LLC
Marketing Status: Prescription
Patent and Exclusivity Information