Details for New Drug Application (NDA): 207325
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The generic ingredient in OXALIPLATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.
Summary for 207325
| Tradename: | OXALIPLATIN |
| Applicant: | Gland |
| Ingredient: | oxaliplatin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207325
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXALIPLATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 207325 | ANDA | Gland Pharma Limited | 68083-176 | 68083-176-01 | 1 VIAL, SINGLE-USE in 1 CARTON (68083-176-01) / 10 mL in 1 VIAL, SINGLE-USE |
| OXALIPLATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 207325 | ANDA | Gland Pharma Limited | 68083-177 | 68083-177-01 | 1 VIAL, SINGLE-USE in 1 CARTON (68083-177-01) / 20 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/10ML (5MG/ML) | ||||
| Approval Date: | Feb 10, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 100MG/20ML (5MG/ML) | ||||
| Approval Date: | Feb 10, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 200MG/40ML (5MG/ML) | ||||
| Approval Date: | Oct 18, 2017 | TE: | RLD: | No | |||||
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