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Last Updated: April 4, 2026

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	sitagliptin phosphate	208186	EQ 50MG BASE	TABLET;ORAL
Zydus Pharms Usa Inc	edoxaban	213064	60MG	TABLET;ORAL
Zydus Pharms Usa Inc	rifaximin	218650	200MG	TABLET
Zydus Pharms Usa Inc	canagliflozin;metformin hydrochloride	210542	50MG;1000MG	TABLET;ORAL
Zydus Pharms Usa Inc	metformin hydrochloride;sitagliptin phosphate	208535	50MG/500MG;50MG/1000MG	TABLET;ORAL
Zydus Pharms Usa Inc	levomilnacipran	210857	80MG	CAPSULE, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc	irbesartan; hydrochlorothiazide	090815	300MG; 25MG	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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