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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203153

TEMSIROLIMUS (TEMSIROLIMUS)
25MG/ML (25MG/ML)
Marketing Status: Prescription
Active Ingredient: TEMSIROLIMUS
Proprietary Name: TEMSIROLIMUS
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 25MG/ML (25MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A203153
Product Number: 001
Approval Date: Jul 30, 2018
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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