FDA Tentative Approval: IRBESARTAN AND HYDROCHLOROTHIAZIDE — Original Application (Macleods Pharmaceuticals Limited)

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Summary

FDA has issued tentative approval for Macleods Pharmaceuticals' generic fixed-dose combination of irbesartan and hydrochlorothiazide for hypertension under ANDA…

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Diseases / indications

• Hypertension

Drugs mentioned

• IRBESARTAN AND HYDROCHLOROTHIAZIDE (irbesartan and hydrochlorothiazide)

Snippet

ORIG TA for IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)