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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022088

TORISEL (TEMSIROLIMUS)
25MG/ML (25MG/ML)
Marketing Status: Prescription
Active Ingredient: TEMSIROLIMUS
Proprietary Name: TORISEL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 25MG/ML (25MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022088
Product Number: 001
Approval Date: May 30, 2007
Applicant Holder Full Name: PF PRISM CV
Marketing Status:  Prescription
Patent and Exclusivity Information
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