Generic Companies with Tentative Approvals for: Zydus Pharms Usa

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Zydus Pharms Usa 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	irbesartan; hydrochlorothiazide	090815	300MG; 12.5MG	TABLET; ORAL
Zydus Pharms Usa Inc	empagliflozin;linagliptin;metformin hydrochloride	217049	12.5MG;2.5MG;1000MG	TABLET, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc	enzalutamide	217322	40MG	TABLET;ORAL
Zydus Pharms Usa Inc	levomilnacipran	210857	20MG	CAPSULE, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc	osimertinib mesylate	214263	80MG	TABLET;ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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