Details for New Drug Application (NDA): 205487
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The generic ingredient in CARBOPLATIN is carboplatin. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
Summary for 205487
Tradename: | CARBOPLATIN |
Applicant: | Eugia Pharma |
Ingredient: | carboplatin |
Patents: | 0 |
Suppliers and Packaging for NDA: 205487
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 205487 | ANDA | Eugia US LLC | 55150-333 | 55150-333-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-333-01) / 5 mL in 1 VIAL, MULTI-DOSE |
CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 205487 | ANDA | Eugia US LLC | 55150-334 | 55150-334-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-334-01) / 15 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) | ||||
Approval Date: | Mar 28, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 150MG/15ML (10MG/ML) | ||||
Approval Date: | Mar 28, 2016 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 450MG/45ML (10MG/ML) | ||||
Approval Date: | Mar 28, 2016 | TE: | AP | RLD: | No |
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