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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_OTC" table for query on "021128."



Active Ingredient: IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage Form;Route: SUSPENSION;ORAL
Proprietary Name: CHILDREN'S MOTRIN COLD
Applicant: MCNEIL CONS
Strength: 100MG/5ML;15MG/5ML
Application Number: N021128
Product Number: 001
Approval Date: Aug 1, 2000
Reference Listed Drug Yes
RX/OTC/DISCN: OTC
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through July 2014
Patent and Generic Drug Product Data Last Updated August 29, 2014

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