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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_Rx" table for query on "020583."



Active Ingredient: LOTEPREDNOL ETABONATE
Dosage Form;Route: SUSPENSION/DROPS;OPHTHALMIC
Proprietary Name: LOTEMAX
Applicant: BAUSCH AND LOMB
Strength: 0.5%
Application Number: N020583
Product Number: 001
Approval Date: Mar 9, 1998
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
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 August 2014
Patent and Generic Drug Product Data Last Updated September 29, 2014

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