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Generated: November 14, 2018

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Details for New Drug Application (NDA): 208264

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NDA 208264 describes TEPADINA, which is a drug marketed by Adienne Sa and is included in one NDA. It is available from two suppliers. Additional details are available on the TEPADINA profile page.

The generic ingredient in TEPADINA is thiotepa. There are eleven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
Summary for 208264
Tradename:TEPADINA
Applicant:Adienne Sa
Ingredient:thiotepa
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208264
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for 208264
Suppliers and Packaging for NDA: 208264
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEPADINA thiotepa POWDER;INTRAVENOUS 208264 NDA ADIENNE SA 53964-001 53964-001-01 1 VIAL, GLASS in 1 BOX (53964-001-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
TEPADINA thiotepa POWDER;INTRAVENOUS 208264 NDA ADIENNE SA 53964-002 53964-002-02 1 VIAL, GLASS in 1 BOX (53964-002-02) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength15MG/VIAL
Approval Date:Jan 26, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 26, 2020
Regulatory Exclusivity Use:FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED WITH HIGH-DOSE BUSULFAN AND CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION FOR PEDIATRIC PATIENTS WITH CLASS 3 BETA-THALASSEMIA
Regulatory Exclusivity Expiration:Jan 26, 2024
Regulatory Exclusivity Use:INDICATED FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED IN CONJUNCTION WITH HIGH-DOSE BUSULFAN & CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENIC HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION FOR PEDS. PATIENTS WITH CLASS 3 BETA-THALASSEMIA

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrength100MG/VIAL
Approval Date:Jan 26, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 26, 2020
Regulatory Exclusivity Use:FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED WITH HIGH-DOSE BUSULFAN AND CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION FOR PEDIATRIC PATIENTS WITH CLASS 3 BETA-THALASSEMIA

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