Generic Companies with Tentative Approvals for: Optimus Pharma Private Ltd
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Optimus Pharma Private Ltd 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 |
---|---|---|---|---|
Optimus Pharma Private Ltd | safinamide | 216020 | 50MG | TABLET;ORAL |
Optimus Pharma Private Ltd | safinamide | 216020 | 100MG | TABLET;ORAL |
Optimus Pharma Private Ltd | obeticholic acid | 214935 | 10mg | TABLET; ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |