The application for the drug was submitted by Ranbaxy, from its Ohm Laboratories manufacturing facility, at New Jersey, US. The Office of Generic Drugs, FDA, had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, accuretic tablets of Pfizer Pharmaceuticals.
This is the second abbreviated new drug application approval granted by the FDA, to Ranbaxy, in the last two months. Quinapril hydrochloride and hydrochlorothiazide, is an angiotensin-converting enzyme inhibitor and is used to treat high blood pressure.