WOODCLIFF LAKE, N.J. — Par Formulations Private Ltd., a subsidary of Par Pharmaceutical Cos., has received its first Abbreviated New Drug Application (ANDA) approval from the Food and Drug Administration.
The company said Friday that Par Formulations, formerly Edict Pharmaceuticals Private Ltd., has been cleared by the FDA to market labetalol HCl tablets in strengths of 100 mg, 200 mg and 300 mg.
The product, slated to be shipped in August, is a generic version of Trandate, indicated for the treatment of hypertension.
Par Pharmaceutical acquired Edict Pharmaceuticals, based in Chennai, India, in February.
