Last Updated: August 18, 2026

Generic Companies with Tentative Approvals for: irbesartan; hydrochlorothiazide

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irbesartan; hydrochlorothiazide 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
Chartwell Rx	irbesartan; hydrochlorothiazide	201524	300MG; 25MG	TABLET; ORAL
Zydus Pharms Usa Inc	irbesartan; hydrochlorothiazide	090815	150MG; 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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