Generic Companies with Tentative Approvals for: macitentan
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macitentan 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 |
---|---|---|---|---|
Sun Pharm Inds | macitentan | 211123 | 10MG | TABLET; ORAL |
Rhodes Pharms | macitentan | 214112 | 10MG | TABLET;ORAL |
Msn Labs Pvt Ltd | macitentan | 211136 | 10MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |