Details for New Drug Application (NDA): 078803
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The generic ingredient in OXALIPLATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
Summary for 078803
Tradename: | OXALIPLATIN |
Applicant: | Actavis Totowa |
Ingredient: | oxaliplatin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078803
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXALIPLATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 078803 | ANDA | Actavis Pharma, Inc. | 45963-611 | 45963-611-59 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-611-59) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/VIAL | ||||
Approval Date: | Aug 8, 2012 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 100MG/VIAL | ||||
Approval Date: | Aug 8, 2012 | TE: | AP | RLD: | No |
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