Details for New Drug Application (NDA): 207324
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NDA 207324 describes CARBOPLATIN, which is a drug marketed by Cipla Ltd, Fresenius Kabi Usa, Hikma, Hospira, Natco Pharma Usa, Pliva, Sandoz, Watson Labs Teva, Accord Hlthcare, Actavis Totowa, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Meitheal, Norvium Bioscience, Novast Labs, Pharmachemie Bv, Pliva Lachema, Sun Pharm, Teva Parenteral, Teva Pharms Usa, and Teyro Labs, and is included in thirty-three NDAs. It is available from eleven suppliers. Additional details are available on the CARBOPLATIN profile page.
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.
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 207324
| Tradename: | CARBOPLATIN |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | carboplatin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207324
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 207324 | ANDA | BPI Labs LLC | 54288-164 | 54288-164-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (54288-164-01) / 5 mL in 1 VIAL, MULTI-DOSE |
| CARBOPLATIN | carboplatin | INJECTABLE;INTRAVENOUS | 207324 | ANDA | BPI Labs LLC | 54288-165 | 54288-165-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (54288-165-01) / 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: | Feb 15, 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 15, 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 15, 2017 | TE: | AP | RLD: | No | ||||
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