NDA 009-321; CHOLOGRAFIN MEGLUMINE (Iodipamide Meglumine Injection USP 52%) CHOLOGRAFIN

Cholografin Meglumine (lodipamide Meglumine Injection 52%) is a radiopaque contrast agent for rapid intravenous cholangiography and cholecystography supplied as a sterile, aqueous solution. Each mL provides 520 mg iodipamide meglumine; at manufacture, 3.2 mg sodium citrate buffer and 0.4 mg edetate disodium sequestering agent are added per mL. The pH has been adjusted between 6.5 and 7.7 with meglumine and iodipamide. Each mL of solution also contains approximately 0.91 mg (0.039 mEq) sodium [18.2 mg/20 mL] and 257 mg organically bound iodine (5.2 g/20 mL). At the time of manufacture, the air in the container is replaced by nitrogen.