Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010040
Company: BRACCO

Products on NDA 10040

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYSTOGRAFIN	DIATRIZOATE MEGLUMINE	30%	SOLUTION;URETHRAL	Prescription	None	Yes	No
CYSTOGRAFIN DILUTE	DIATRIZOATE MEGLUMINE	18%	SOLUTION;URETHRAL	Prescription	None	Yes	No
DIATRIZOATE MEGLUMINE	DIATRIZOATE MEGLUMINE	76%	INJECTABLE;INJECTION	Discontinued	None	No	No
RENO-30	DIATRIZOATE MEGLUMINE	30%	SOLUTION;URETERAL	Discontinued	None	No	No
RENO-60	DIATRIZOATE MEGLUMINE	60%	INJECTABLE;INJECTION	Discontinued	None	No	No
RENO-DIP	DIATRIZOATE MEGLUMINE	30%	INJECTABLE;INJECTION	Discontinued	None	No	No
RENOGRAFIN-60	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	52%;8%	INJECTABLE;INJECTION	Discontinued	None	No	No
RENOGRAFIN-76	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	66%;10%	INJECTABLE;INJECTION	Discontinued	None	Yes	No
RENOVIST	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	34.3%;35%	INJECTABLE;INJECTION	Discontinued	None	No	No
RENOVIST II	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM	28.5%;29.1%	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for NDA 010040

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/06/2015	SUPPL-171	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/010040s171lbl.pdf