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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 "020827."



Active Ingredient: MICONAZOLE NITRATE
Dosage Form;Route: CREAM;VAGINAL
Proprietary Name: MONISTAT 3
Applicant: INSIGHT PHARMS
Strength: 4%
Application Number: N020827
Product Number: 001
Approval Date: Mar 30, 1998
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 June 2014
Patent and Generic Drug Product Data Last Updated July 23, 2014

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