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	amlodipine besylate; benazepril hydrochloride	078652	2.5MG; 10MG	CAPSULE; ORAL
Zydus Pharms Usa Inc	glipizide	203499	2.5MG	TABLET, EXTENDED RELEASE;ORAL
Zydus Pharms Usa Inc	irbesartan; hydrochlorothiazide	090815	300MG; 12.5MG	TABLET; ORAL
Zydus Pharms Usa Inc	irbesartan; hydrochlorothiazide	090815	300MG; 25MG	TABLET; ORAL
>Applicant	>Generic Name	>NDA	>Strength	>Dosage Form

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