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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202509

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE (DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE)
0.5MG;0.4MG
Marketing Status: Prescription
Active Ingredient: DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Proprietary Name: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.5MG;0.4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202509
Product Number: 001
Approval Date: Feb 26, 2014
Applicant Holder Full Name: ANCHEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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