Generic Companies with Tentative Approvals for: Zydus Pharms

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Zydus Pharms 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
Zydus Pharms Usa Inc	empagliflozin;linagliptin;metformin hydrochloride	217049	12.5MG;2.5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
Zydus Pharms	vortioxetine hydrobromide	211146	EQ 10MG BASE	TABLET;ORAL
Zydus Pharms Usa Inc	sitagliptin phosphate	208186	EQ 25MG BASE	TABLET;ORAL
Zydus Pharms Usa Inc	osimertinib mesylate	214263	80MG	TABLET;ORAL
Zydus Pharms Usa Inc	edaravone	218349	30MG/100ML(0.3MG/ML)	INJECTABLE;INJECTION
Zydus Pharms Usa Inc	canagliflozin;metformin hydrochloride	210542	50MG;1000MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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