Unichem Laboratories has received ANDA approval for its Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg, and 300 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Normodyne (Labetalol Hydrochloride) Tablets 100 mg, 200 mg and 400 mg, of Schering Corp Sub Schering Plough Corp.
Labetalol Hydrochloride tablets are indicated for the management of hypertension. The product will be commercialized from Unichem’s Goa Plant.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company.