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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 |
---|---|---|---|---|
Actavis Llc | cabazitaxel | 207970 | 60MG/6ML | INJECTABLE;INJECTION |
Fresenius Kabi Usa | cabazitaxel | 207937 | 20MG/ML | INJECTABLE;INJECTION |
Accord Hlthcare Inc | cabazitaxel | 207949 | 20MG/ML(60MG/3ML) | INJECTABLE;INJECTION |
Apotex Inc | cabazitaxel | 207736 | 60MG/1.5ML (40MG/ML) | SOLUTION;IV (INFUSION) |
Sandoz Inc | cabazitaxel | 208715 | 60MG/6ML | INJECTABLE;INJECTION |
Actavis Llc | cabazitaxel | 207970 | 40MG/4ML | INJECTABLE;INJECTION |
Accord Hlthcare Inc | cabazitaxel | 207693 | 60MG/1.5ML(40MG/ML) | INJECTABLE;INJECTION |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |