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 one supplier. 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. Nine suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
The generic ingredient in TEPADINA is thiotepa. There are eleven drug master file entries for this compound. Nine 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 Action | Alkylating 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;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 208264 | NDA | Amneal Pharmaceuticals LLC | 70121-1630 | 70121-1630-1 | 1 VIAL, GLASS in 1 BOX (70121-1630-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
| TEPADINA | thiotepa | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | 208264 | NDA | Amneal Pharmaceuticals LLC | 70121-1631 | 70121-1631-1 | 1 VIAL, GLASS in 1 BOX (70121-1631-1) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | Strength | 15MG/VIAL | ||||
| Approval Date: | Jan 26, 2017 | TE: | AP | RLD: | Yes | ||||
| 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: | RX | Dosage: | POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL | Strength | 100MG/VIAL | ||||
| Approval Date: | Jan 26, 2017 | TE: | AP | RLD: | Yes | ||||
| 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 | ||||||||
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