Generic Companies with Tentative Approvals for: Zydus

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Zydus 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	osimertinib mesylate	214263	40MG	TABLET;ORAL
Zydus Lifesciences	darunavir	214085	150MG	TABLET;ORAL
Zydus Pharms Usa Inc	amlodipine besylate; benazepril hydrochloride	078652	10MG; 20MG	CAPSULE; ORAL
Zydus Pharms Usa Inc	levomilnacipran	210857	120MG	CAPSULE, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc	empagliflozin;linagliptin;metformin hydrochloride	217049	5MG;2.5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc	cinacalcet hydrochloride	208971	EQ 60MG BASE	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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