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Last Updated: September 28, 2020

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Generic Companies with Tentative Approvals for: dimethyl fumarate

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dimethyl fumarate 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
Glenmark Pharms dimethyl fumarate 210309 120MG CAPSULE, DELAYED RELEASE;ORAL
Shilpa Medicare Ltd dimethyl fumarate 210291 240MG CAPSULE, DELAYED RELEASE;ORAL
Accord Hlthcare Inc dimethyl fumarate 210499 120MG CAPSULE, DELAYED RELEASE;ORAL
Twi Pharms Inc dimethyl fumarate 210382 240MG CAPSULE, EXTENDED RELEASE;ORAL
Lupin Atlantis dimethyl fumarate 210226 240MG CAPSULE, DELAYED RELEASE;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Baxter
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McKinsey
McKesson

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