Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075643

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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: A075643
Product Number: 001
Approval Date: Nov 16, 2000
Applicant Holder Full Name: CASI PHARMACEUTICALS INC
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: No
TE Code: AB
Application Number: A075643
Product Number: 002
Approval Date: Nov 16, 2000
Applicant Holder Full Name: CASI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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