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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 "020603."



Active Ingredient: IBUPROFEN
Dosage Form;Route: SUSPENSION/DROPS;ORAL
Proprietary Name: CHILDREN'S MOTRIN
Applicant: MCNEIL CONS
Strength: 40MG/ML
Application Number: N020603
Product Number: 001
Approval Date: Jun 10, 1996
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 November 2014
Patent and Generic Drug Product Data Last Updated December 19, 2014

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