Application 010040

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RENOGRAFIN-76	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	INJECTABLE;INJECTION	66%;10%	Yes	No
006	RENOGRAFIN-60	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	INJECTABLE;INJECTION	52%;8%	No	No
012	RENO-DIP	DIATRIZOATE MEGLUMINE	INJECTABLE;INJECTION	30%	No	No
016	RENO-60	DIATRIZOATE MEGLUMINE	INJECTABLE;INJECTION	60%	No	No
017	DIATRIZOATE MEGLUMINE	DIATRIZOATE MEGLUMINE	INJECTABLE;INJECTION	76%	No	No
018	CYSTOGRAFIN	DIATRIZOATE MEGLUMINE	SOLUTION;URETHRAL	30%	Yes	No
019	RENOVIST II	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	INJECTABLE;INJECTION	28.5%;29.1%	No	No
020	RENOVIST	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	INJECTABLE;INJECTION	34.3%;35%	No	No
021	RENO-30	DIATRIZOATE MEGLUMINE	SOLUTION;URETERAL	30%	No	No
022	CYSTOGRAFIN DILUTE	DIATRIZOATE MEGLUMINE	SOLUTION;URETHRAL	18%	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0270-0149	Cystografin	diatrizoate meglumine	BRACCO DIAGNOSTICS INC	NDA	Current
0270-1410	Cystografin Dilute	diatrizoate meglumine	BRACCO DIAGNOSTICS INC	NDA	Current