Last Updated: July 18, 2026

Generic Companies with Tentative Approvals for: Mylan

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Mylan 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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Glossary

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Applicant	Generic Name	NDA	Strength	Dosage Form
Mylan Labs Ltd	bivalirudin	091468	250MG/VIAL	INJECTABLE;INJECTION
Mylan Pharms Inc	sertraline hydrochloride	076540	EQ 100MG BASE	TABLET;ORAL
Mylan Pharms Inc	sitagliptin phosphate	202473	EQ 50MG BASE	TABLET; ORAL
Mylan Labs Ltd	emtricitabine, tenofovir alafenamide	211148	120MG	TABLET; ORAL
Mylan Pharma	levofloxacin	090063	250MG	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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