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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022277

Marketing Status: Prescription
Active Ingredient: TEMOZOLOMIDE
Proprietary Name: TEMODAR
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: 100MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022277
Product Number: 001
Approval Date: Feb 27, 2009
Applicant Holder Full Name: MERCK SHARP AND DOHME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
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