Generic Companies with Tentative Approvals for: darunavir
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darunavir 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 |
---|---|---|---|---|
Teva Pharms Usa | darunavir | 202118 | 400MG | TABLET;ORAL |
Mylan Pharms Inc | darunavir | 202136 | 300MG | TABLET; ORAL |
Teva Pharms Usa | darunavir | 202118 | 150MG | TABLET;ORAL |
Micro Labs Usa | darunavir ethanolate | 210187 | 150MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |