Details for New Drug Application (NDA): 206775
The generic ingredient in CARBOPLATIN is carboplatin. There is one drug master file entry for this compound. Eleven suppliers are listed for this compound. Additional details are available on the carboplatin profile page.
Summary for 206775
| Tradename: | CARBOPLATIN |
| Applicant: | Accord Hlthcare |
| Ingredient: | carboplatin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206775
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 206775 | ANDA | Accord Healthcare, Inc. | 16729-295 | 16729-295-12 | 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-12) / 60 mL in 1 VIAL, MULTI-DOSE |
| CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 206775 | ANDA | Accord Healthcare, Inc. | 16729-295 | 16729-295-31 | 1 VIAL, MULTI-DOSE in 1 CARTON (16729-295-31) / 5 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: | Feb 9, 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: | Feb 9, 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: | Feb 9, 2017 | TE: | AP | RLD: | No | ||||
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