FDA Approval Activities for this Drug…

Cystographin Dilute (Diatrizoate Meglumine) Injection USP, 18% Bracco Diagnostics, 10-040/SPD-163 Hypaque-Cysto (brand of diatrizoate meglumine), Amersham Health NDA 16-403/SLR-071 Renografin-60 - (Diatrizoate Meglumine and Diatrizoate Sodium Injection USP), Bracco Diagnostics NDA 10-040/SLR-168 Sinografin (diatrizoate meglumine and iodipimide meglumine injection), Bracco Diagnostics NDA 11-324/S-028 DIATRIZOATE MEGLUMINE Injection 30% HYPAQUE AMERSHAM HLTH 016403 DIATRIZOATE MEGLUMINE Injection 60% HYPAQUE AMERSHAM HLTH 010040 DIATRIZOATE MEGLUMINE Injection 30% RENO-DIP BRACCO 010040 DIATRIZOATE MEGLUMINE Injection 60% RENO-60 BRACCO 010040 DIATRIZOATE MEGLUMINE Solution; Ureteral 30% RENO-30 BRACCO 016403 AT DIATRIZOATE MEGLUMINE Solution; Urethral 30% HYPAQUE-CYSTO AMERSHAM HLTH 010040 DIATRIZOATE MEGLUMINE Solution; Urethral 18% CYSTOGRAFIN DILUTE BRACCO 010040 AT DIATRIZOATE MEGLUMINE Solution; Urethral 30% CYSTOGRAFIN BRACCO 086505 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM Injection 66%;10% HYPAQUE-76 AMERSHAM HLTH 010040 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM Injection 52%;8% RENOGRAFIN-60 BRACCO 010040 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM Injection 66%;10% RENOGRAFIN-76 BRACCO 089347 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM Injection 66%;10% RENOCAL-76 BRACCO 019292 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM Injection 66%;10% MD-76R Mallinckrodt 011245 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM Solution; , Rectal 66%;10% GASTROGRAFIN BRACCO 087388 DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM Solution; , Rectal 66%;10% MD-GASTROVIEW Mallinckrodt 011324 DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE Solution; Intrauterine 52.7%;26.8% SINOGRAFIN BRACCO 011386 DIATRIZOATE SODIUM For Solution; , Rectal 100% HYPAQUE AMERSHAM HLTH 009561 DIATRIZOATE SODIUM Injection 50% HYPAQUE AMERSHAM HLTH

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