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Last Updated: April 5, 2020

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Generic Companies with Tentative Approvals


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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
Mylan Pharms Inc fluconazole 076042 150MG TABLET;ORAL
Micro Labs Ltd lamivudine 200406 300MG TABLET; ORAL
Cadila Pharms Ltd pregabalin 206452 225MG CAPSULE;ORAL
Mylan Pharms Inc dalfampridine 206858 10MG TABLET, EXTENDED RELEASE;ORAL
Sandoz Inc maraviroc 203382 150MG TABLET;ORAL
Roxane tapentadol 205057 100MG TABLET;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
McKesson
Mallinckrodt
Dow
Baxter

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