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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_Disc" table for query on "021335."



Active Ingredient: IMATINIB MESYLATE
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: GLEEVEC
Applicant: NOVARTIS
Strength: EQ 50MG BASE
Application Number: N021335
Product Number: 001
Approval Date: May, 10, 2001
RX/OTC/DISCN: DISCN
Patent and Exclusivity Info for this product: View

Active Ingredient: IMATINIB MESYLATE
Dosage Form;Route: CAPSULE;ORAL
Proprietary Name: GLEEVEC
Applicant: NOVARTIS
Strength: EQ 100MG BASE
Application Number: N021335
Product Number: 002
Approval Date: May, 10, 2001
RX/OTC/DISCN: DISCN
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 17, 2014

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