Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204800

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FELODIPINE (FELODIPINE)
2.5MG
Marketing Status: Prescription

Active Ingredient: FELODIPINE
Proprietary Name: FELODIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204800
Product Number: 001
Approval Date: Apr 29, 2019
Applicant Holder Full Name: YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

FELODIPINE (FELODIPINE)
5MG
Marketing Status: Prescription

Active Ingredient: FELODIPINE
Proprietary Name: FELODIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204800
Product Number: 002
Approval Date: Apr 29, 2019
Applicant Holder Full Name: YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

FELODIPINE (FELODIPINE)
10MG
Marketing Status: Prescription

Active Ingredient: FELODIPINE
Proprietary Name: FELODIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204800
Product Number: 003
Approval Date: Apr 29, 2019
Applicant Holder Full Name: YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information