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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215423

ENTADFI (FINASTERIDE; TADALAFIL)
5MG;5MG
Marketing Status: Prescription
Active Ingredient: FINASTERIDE; TADALAFIL
Proprietary Name: ENTADFI
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG;5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N215423
Product Number: 001
Approval Date: Dec 9, 2021
Applicant Holder Full Name: BLUE WATER BIOTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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