Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209525

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ICOSAPENT ETHYL (ICOSAPENT ETHYL)
500MG
Marketing Status: Prescription

Active Ingredient: ICOSAPENT ETHYL
Proprietary Name: ICOSAPENT ETHYL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209525
Product Number: 001
Approval Date: Sep 11, 2020
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

ICOSAPENT ETHYL (ICOSAPENT ETHYL)
1GM
Marketing Status: Prescription

Active Ingredient: ICOSAPENT ETHYL
Proprietary Name: ICOSAPENT ETHYL
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 1GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209525
Product Number: 002
Approval Date: Sep 11, 2020
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information