Details for New Drug Application (NDA): 201023
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The generic ingredient in JEVTANA KIT is cabazitaxel. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cabazitaxel profile page.
Summary for 201023
| Tradename: | JEVTANA KIT |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | cabazitaxel |
| Patents: | 5 |
Suppliers and Packaging for NDA: 201023
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023 | NDA | Sanofi-Aventis U.S. LLC | 0024-5824 | 0024-5824-11 | 1 KIT in 1 CARTON (0024-5824-11) * 5.7 mL in 1 VIAL, GLASS (0024-5823-15) * 5.7 mL in 1 VIAL, GLASS (0024-5822-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 60MG/1.5ML (40MG/ML) | ||||
| Approval Date: | Jun 17, 2010 | TE: | AP | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 27, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 27, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 27, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 201023
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Start Trial | ⤷ Start Trial |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Start Trial | ⤷ Start Trial |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Start Trial | ⤷ Start Trial |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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