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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021319

AVODART (DUTASTERIDE)
0.5MG
Marketing Status: Prescription
Active Ingredient: DUTASTERIDE
Proprietary Name: AVODART
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021319
Product Number: 001
Approval Date: Nov 20, 2001
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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