Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder

摘要

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for an additional container size for the firm's oxytetracycline hydrochloride (OTC HCl) soluble powder. The drug product is administered orally in drinking water for either control or control and treatment of certain diseases of chickens, turkeys, swine, cattle, and sheep. In addition, the regulations are amended to specify the withdrawal period for use of medicated drinking water made from the subject sponsor's drug and to add certain warning statements required on the labeling.