FDA Discontinues HALOPERIDOL Injectable (ANDA070802)

The U.S. Food and Drug Administration (FDA) has recorded the status of a HALOPERIDOL injectable product as discontinued. The submission, identified by application number ANDA070802, was filed by sponsor Smith & Nephew. The product is listed as an injectable dosage form (product number 001) and is not designated as a reference drug. Its active ingredient is HALOPERIDOL LACTATE, equivalent to 5 mg per milliliter of HALOPERIDOL base. The marketing status is noted as discontinued. No further details were provided in the FDA notice.