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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204627

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE)
4MG/5ML;5MG/5ML;60MG/5ML
Marketing Status: Prescription
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: Yes
TE Code: 
Application Number: A204627
Product Number: 001
Approval Date: Apr 29, 2014
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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