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Product Details for ANDA 091632

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX (CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX)
EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
Marketing Status: Prescription
Active Ingredient: CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
Proprietary Name: HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; ORAL
Strength: EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A091632
Product Number: 001
Approval Date: Oct 1, 2010
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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