Generic Companies with Tentative Approvals for: bosentan
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bosentan 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 |
---|---|---|---|---|
Chartwell Molecular | bosentan | 210342 | 125MG | TABLET;ORAL |
Zydus Pharms Usa Inc | bosentan | 213981 | 32MG | TABLET;ORAL |
Natco Pharma Ltd | bosentan | 213154 | 32MG | TABLET, FOR SUSPENSION;ORAL |
Chartwell Molecular | bosentan | 210342 | 62.5MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |