Details for New Drug Application (NDA): 201023
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The generic ingredient in JEVTANA KIT is cabazitaxel. There are thirteen drug master file entries 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: | ⤷ Get Started Free | Patent Expiration: | Apr 27, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Apr 27, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Get Started Free | 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 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | JEVTANA KIT | cabazitaxel | SOLUTION;INTRAVENOUS | 201023-001 | Jun 17, 2010 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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