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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216984

TEPYLUTE (THIOTEPA)
15MG/1.5ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: THIOTEPA
Proprietary Name: TEPYLUTE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 15MG/1.5ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216984
Product Number: 001
Approval Date: Jun 25, 2024
Applicant Holder Full Name: SHORLA PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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