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Last Updated: October 26, 2021

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Generic Companies with Tentative Approvals for: Micro Labs


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Micro Labs 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
Micro Labs Ltd pirfenidone 212680 267MG TABLET; ORAL
Micro Labs Ltd pirfenidone 212680 801MG TABLET;ORAL
Micro Labs Ltd India efavirenz 205389 100MG TABLET;ORAL
Micro Labs Ltd lamivudine 200406 300MG TABLET; ORAL
Micro Labs Ltd efavirenz 202301 600MG TABLET; ORAL
Micro Labs Ltd tofacitinib 209738 5MG TABLET;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
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Boehringer Ingelheim
Mallinckrodt
Baxter

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