Generic Companies with Tentative Approvals for: bivalirudin
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bivalirudin 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 |
---|---|---|---|---|
Mylan Labs Ltd | bivalirudin | 091468 | 250MG/VIAL | INJECTABLE;INJECTION |
Pliva Hrvatska Doo | bivalirudin | 091206 | 250MG/VIAL | INJECTABLE;INTRAVENOUS |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |