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Last Updated: March 7, 2021

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Generic Companies with Tentative Approvals for: Mylan Labs Ltd

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Mylan Labs Ltd 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 Labs Ltd emtricitabine;tenofovir disoproxil fumarate;nevirapine 206042 200MG;300MG;200MG TABLET;ORAL
Mylan Labs Ltd posaconazole 211500 300MG/16.7ML (18MG/ML) SOLUTION;INTRAVENOUS
Mylan Labs Ltd lamivudine;zidovudine;efavirenz 206040 150MG;300MG;600MG TABLET;ORAL
Mylan Labs Ltd bendamustine hydrochloride 204104 25MG/VIAL POWDER;IV (INFUSION)
Mylan Labs Ltd atazanavir sulfate;ritonavir;lamivudine;zidovudine 206041 300MG;100MG;150MG;300MG TABLET;ORAL
Mylan Labs Ltd bivalirudin 091468 250MG/VIAL INJECTABLE;INJECTION
Mylan Labs Ltd dolutegravir sodium 209602 50MG TABLET;ORAL
>Applicant >Generic Name >NDA >Strength >Dosage Form

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