Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078635

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BISOPROLOL FUMARATE (BISOPROLOL FUMARATE)
5MG
Marketing Status: Prescription

Active Ingredient: BISOPROLOL FUMARATE
Proprietary Name: BISOPROLOL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078635
Product Number: 001
Approval Date: Aug 18, 2009
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

BISOPROLOL FUMARATE (BISOPROLOL FUMARATE)
10MG
Marketing Status: Prescription

Active Ingredient: BISOPROLOL FUMARATE
Proprietary Name: BISOPROLOL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A078635
Product Number: 002
Approval Date: Aug 18, 2009
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information