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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203838

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE)
4MG/5ML;5MG/5ML;60MG/5ML
Marketing Status: Discontinued
Active Ingredient: CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 4MG/5ML;5MG/5ML;60MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A203838
Product Number: 001
Approval Date: Nov 26, 2014
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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