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Last Updated: September 23, 2020

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Generic Companies with Tentative Approvals for: Glenmark Pharms

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Glenmark Pharms 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 Ltd milnacipran hydrochloride 205267 25MG TABLET;ORAL
Glenmark Pharms Ltd lacosamide 205006 150MG TABLET;ORAL
Glenmark Pharms Ltd topiramate 210278 100MG CAPSULE, EXTENDED RELEASE;ORAL
Glenmark Pharms Ltd dabigatran etexilate 207984 150MG CAPSULE;ORAL
Glenmark Pharms dimethyl fumarate 210309 240MG CAPSULE, DELAYED RELEASE;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
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Baxter
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McKinsey

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