Details for New Drug Application (NDA): 208487
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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 208487
Tradename: | CARBOPLATIN |
Applicant: | Novast Labs |
Ingredient: | carboplatin |
Patents: | 0 |
Suppliers and Packaging for NDA: 208487
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 208487 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-447 | 50742-447-45 | 1 VIAL, MULTI-DOSE in 1 CARTON (50742-447-45) / 45 mL in 1 VIAL, MULTI-DOSE |
CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 208487 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-448 | 50742-448-60 | 1 VIAL, MULTI-DOSE in 1 CARTON (50742-448-60) / 60 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: | Apr 26, 2017 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 150MG/15ML (10MG/ML) | ||||
Approval Date: | Apr 26, 2017 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 450MG/45ML (10MG/ML) | ||||
Approval Date: | Apr 26, 2017 | TE: | AP | RLD: | No |
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