Details for New Drug Application (NDA): 207381
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NDA 207381 describes CABAZITAXEL, which is a drug marketed by Accord Hlthcare, Actavis, Apotex, Breckenridge, Dr Reddys, and Mylan Labs Ltd, and is included in seven NDAs. Additional details are available on the CABAZITAXEL profile page.
The generic ingredient in CABAZITAXEL is cabazitaxel. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabazitaxel profile page.
The generic ingredient in CABAZITAXEL is cabazitaxel. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cabazitaxel profile page.
Summary for 207381
| Tradename: | CABAZITAXEL |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | cabazitaxel |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 60MG/1.5ML (40MG/ML) | ||||
| Approval Date: | Jul 5, 2023 | TE: | RLD: | No | |||||
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