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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.

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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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