Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208264

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TEPADINA (THIOTEPA)
15MG/VIAL Marketing Status: Prescription

Active Ingredient: THIOTEPA
Proprietary Name: TEPADINA
Dosage Form; Route of Administration: POWDER; IV (INFUSION)
Strength: 15MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208264
Product Number: 001
Approval Date: Jan 26, 2017
Applicant Holder Full Name: ADIENNE SA
Marketing Status:  Prescription
Patent and Exclusivity Information

TEPADINA (THIOTEPA)
100MG/VIAL Marketing Status: Prescription

Active Ingredient: THIOTEPA
Proprietary Name: TEPADINA
Dosage Form; Route of Administration: POWDER; IV (INFUSION)
Strength: 100MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208264
Product Number: 002
Approval Date: Jan 26, 2017
Applicant Holder Full Name: ADIENNE SA
Marketing Status:  Prescription
Patent and Exclusivity Information

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