Generic Companies with Tentative Approvals for: Shilpa Medicare
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Shilpa Medicare 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 |
---|---|---|---|---|
Shilpa Medicare Ltd | apremilast | 211774 | 10MG | TABLET;ORAL |
Shilpa Medicare Ltd | dimethyl fumarate | 210291 | 120MG | CAPSULE, DELAYED RELEASE;ORAL |
Shilpa Medicare Ltd | apremilast | 211774 | 20MG | TABLET;ORAL |
Shilpa Medicare Ltd | apremilast | 211774 | 30MG | TABLET;ORAL |
>Applicant | >Generic Name | >NDA | >Strength | >Dosage Form |