Details for New Drug Application (NDA): 021759
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The generic ingredient in ELOXATIN is oxaliplatin. There is one drug master file entry for this compound. Sixteen 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 |
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| Strength | 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| Strength | 100MG/20ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| Strength | 200MG/40ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
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