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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207768

TUZISTRA XR (CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX)
EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML
Marketing Status: Discontinued
Active Ingredient: CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX
Proprietary Name: TUZISTRA XR
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; ORAL
Strength: EQ 2.8MG BASE/5ML;EQ 14.7MG BASE/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207768
Product Number: 001
Approval Date: Apr 30, 2015
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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