Generic Companies with Tentative Approvals for: cabazitaxel
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cabazitaxel Generic Filers with Tentative Approvals
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Applicant | Generic Name | NDA | Strength | Dosage Form |
---|---|---|---|---|
Fresenius Kabi Usa | cabazitaxel | 207937 | 20MG/ML | INJECTABLE;INJECTION |
Bpi Labs Llc | cabazitaxel | 207735 | UNKNOWN | UNKNOWN |
Sandoz | cabazitaxel | 208715 | 45MG/4.5ML (10MG/ML) | SOLUTION;INTRAVENOUS |
Sandoz | cabazitaxel | 208715 | 60MG/6ML (10MG/ML) | SOLUTION;INTRAVENOUS |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |