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Last Updated: April 19, 2025

Generic Companies with Tentative Approvals for: Mylan Labs

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Mylan 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.

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Applicant	Generic Name	NDA	Strength	Dosage Form
Mylan Labs Ltd	emtricitabine;tenofovir disoproxil fumarate;nevirapine	206042	200MG;300MG;200MG	TABLET;ORAL
Mylan Labs	abacavir sulfate; lamivudine	202381	60MG; 30MG	TABLET; ORAL
Mylan Labs Ltd	emtricitabine, tenofovir alafenamide	211148	200MG	TABLET; ORAL
Mylan Labs Ltd	atazanavir sulfate;ritonavir;lamivudine;zidovudine	206041	300MG;100MG;150MG;300MG	TABLET;ORAL
Mylan Labs Ltd	methylnaltrexone bromide	208592	12MG/0.6ML	INJECTABLE;SUBCUTANEOUS
Mylan Labs Ltd	dolutegravir sodium	209602	50MG	TABLET;ORAL
Mylan Labs Ltd	lamivudine;zidovudine;efavirenz	206040	150MG;300MG;600MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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