Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206672

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ENTECAVIR (ENTECAVIR)
0.5MG
Marketing Status: Prescription
Active Ingredient: ENTECAVIR
Proprietary Name: ENTECAVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206672
Product Number: 001
Approval Date: May 11, 2017
Applicant Holder Full Name: CASI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ENTECAVIR (ENTECAVIR)
1MG
Marketing Status: Prescription
Active Ingredient: ENTECAVIR
Proprietary Name: ENTECAVIR
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206672
Product Number: 002
Approval Date: May 11, 2017
Applicant Holder Full Name: CASI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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