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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204516

BRISDELLE (PAROXETINE MESYLATE)
EQ 7.5MG BASE
Marketing Status: Prescription
Active Ingredient: PAROXETINE MESYLATE
Proprietary Name: BRISDELLE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 7.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N204516
Product Number: 001
Approval Date: Jun 28, 2013
Applicant Holder Full Name: LEGACY PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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