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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 "019012."



Active Ingredient: IBUPROFEN
Dosage Form;Route: TABLET;ORAL
Proprietary Name: MOTRIN IB
Applicant: MCNEIL
Strength: 200MG
Application Number: N019012
Product Number: 003
Approval Date: Dec 17, 1990
Reference Listed Drug Yes
RX/OTC/DISCN: OTC
Patent and Exclusivity Info for this product: View

Active Ingredient: IBUPROFEN
Dosage Form;Route: TABLET;ORAL
Proprietary Name: MOTRIN MIGRAINE PAIN
Applicant: MCNEIL
Strength: 200MG
Application Number: N019012
Product Number: 004
Approval Date: Feb 25, 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 September 2014
Patent and Generic Drug Product Data Last Updated October 21, 2014

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