Details for New Drug Application (NDA): 021759
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NDA 021759 describes ELOXATIN, which is a drug marketed by Sanofi Aventis Us and is included in two NDAs. It is available from one supplier. Additional details are available on the ELOXATIN profile page.
The generic ingredient in ELOXATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
The generic ingredient in ELOXATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
Summary for 021759
| Tradename: | ELOXATIN |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | oxaliplatin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021759
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759 | NDA AUTHORIZED GENERIC | Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1731 | 0955-1731-10 | 1 VIAL, GLASS in 1 CARTON (0955-1731-10) / 10 mL in 1 VIAL, GLASS |
| ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759 | NDA AUTHORIZED GENERIC | Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1733 | 0955-1733-20 | 1 VIAL, GLASS in 1 CARTON (0955-1733-20) / 20 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 31, 2005 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jan 31, 2005 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 17, 2006 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021759
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759-003 | Nov 17, 2006 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759-002 | Jan 31, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759-003 | Nov 17, 2006 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759-001 | Jan 31, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759-002 | Jan 31, 2005 | ⤷ Get Started Free | ⤷ Get Started Free |
| Sanofi Aventis Us | ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759-003 | Nov 17, 2006 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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