FDA Approves Irbesartan/Hydrochlorothiazide Combination Tablets (ANDA 077446)

The U.S. Food and Drug Administration has granted approval for two oral tablet products that combine irbesartan and hydrochlorothiazide under ANDA 077446. Both products are prescription‑only, administered orally, and are classified under TE code AB. Product 001 is a tablet containing 150 mg irbesartan and 12.5 mg hydrochlorothiazide. Product 002 is a tablet containing 300 mg irbesartan and 12.5 mg hydrochlorothiazide. Neither product is listed as a reference drug or reference standard. The applications included a series of supplemental (SUPPL) submissions for labeling (submission numbers 6 through 15). All supplemental submissions were approved (status “AP”) with labeling class codes, and approval dates range from February 2015 to June 2026, reflecting ongoing updates to the product labeling. These approvals expand the FDA‑cleared fixed‑dose combination antihypertensive options available to prescribers.