Details for New Drug Application (NDA): 207385
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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 207385
Tradename: | OXALIPLATIN |
Applicant: | Gland Pharma Ltd |
Ingredient: | oxaliplatin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 207385
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXALIPLATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 207385 | ANDA | Gland Pharma Limited | 68083-170 | 68083-170-01 | 10 mL in 1 VIAL (68083-170-01) |
OXALIPLATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 207385 | ANDA | Gland Pharma Limited | 68083-171 | 68083-171-01 | 20 mL in 1 VIAL (68083-171-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/VIAL | ||||
Approval Date: | May 23, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 100MG/VIAL | ||||
Approval Date: | May 23, 2017 | TE: | AP | RLD: | No |
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