In the May 15, 1996 Federal Register, FDA published a final rule to reflect that two new animal drug applications (NADA's) held by Schering-Plough Animal Health were being combined into one, one NADA was being withdrawn, a supplemental NADA was being approved, and a tolerance for residues of gentamicin in chickens was being added.

The firm requested that NADA 47-486 for Garasol ® Injection (5 mg. gentamicin per ml) for turkeys be included in NADA 101-862 Garasol ®. The NADAs are combined as NADA 101-862. NADA 47-486 is withdrawn.

Schering-Plough also filed a supplemental NADA (101-862) providing for the use of 50 and 100 mg/ml gentamicin sulfate injection for turkeys at the same dosage and for the same indications as currently approved. In addition, Title 21, Part 566.300 of the Code of Federal Regulations, is amended to provide for tolerances for gentamicin residues in chickens as well as turkeys.