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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019111

TUSSIONEX PENNKINETIC (CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX)
EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
Proprietary Name: TUSSIONEX PENNKINETIC
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; ORAL
Strength: EQ 8MG MALEATE/5ML;EQ 10MG BITARTRATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N019111
Product Number: 001
Approval Date: Dec 31, 1987
Applicant Holder Full Name: UCB INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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