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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021128

CHILDREN'S MOTRIN COLD (IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE)
100MG/5ML;15MG/5ML
Marketing Status: Over-the-counter
Active Ingredient: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S MOTRIN COLD
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 100MG/5ML;15MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021128
Product Number: 001
Approval Date: Aug 1, 2000
Applicant Holder Full Name: JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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