Rhone Merieux, Inc.; Withdrawal of Approval of NADA

Streszczenie

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) held by Rhone Merieux, Inc. The NADA provides for the use of Gallimycin (erythromycin) Poultry Formula in poultry drinking water. The sponsor requested the withdrawal of approval because the animal drug product is no longer manufactured or marketed.