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Last Updated: October 24, 2021

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Generic Companies with Tentative Approvals for: Shilpa Medicare Ltd


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Shilpa Medicare 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
Shilpa Medicare Ltd dimethyl fumarate 210291 120MG CAPSULE, DELAYED RELEASE;ORAL
Shilpa Medicare Ltd apremilast 211774 20MG TABLET;ORAL
Shilpa Medicare Ltd apremilast 211774 10MG TABLET;ORAL
Shilpa Medicare Ltd apremilast 211774 30MG TABLET;ORAL
Shilpa Medicare Ltd dimethyl fumarate 210291 240MG CAPSULE, DELAYED RELEASE;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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