Details for New Drug Application (NDA): 208264
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NDA 208264 describes TEPADINA AND SODIUM CHLORIDE, which is a drug marketed by Adienne Sa and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TEPADINA AND SODIUM CHLORIDE profile page.
The generic ingredient in TEPADINA AND SODIUM CHLORIDE is thiotepa. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
The generic ingredient in TEPADINA AND SODIUM CHLORIDE is thiotepa. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the thiotepa profile page.
Summary for 208264
| Tradename: | TEPADINA AND SODIUM CHLORIDE |
| Applicant: | Adienne Sa |
| Ingredient: | thiotepa |
| Patents: | 1 |
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 | ||||
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 | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 200MG | ||||
| Approval Date: | Apr 10, 2025 | TE: | RLD: | Yes | |||||
| Patent: | 9,931,458 | Patent Expiration: | May 31, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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