Details for New Drug Application (NDA): 010040

NDA 010040 describes CYSTOGRAFIN DILUTE, which is a drug marketed by Bracco and is included in one NDA. It is available from one supplier. Additional details are available on the CYSTOGRAFIN DILUTE profile page.

The generic ingredient in CYSTOGRAFIN DILUTE is diatrizoate meglumine. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diatrizoate meglumine profile page.

Summary for 010040

Tradename:	CYSTOGRAFIN DILUTE
Applicant:	Bracco
Ingredient:	diatrizoate meglumine; diatrizoate sodium
Patents:	0

Pharmacology for NDA: 010040

Mechanism of Action

X-Ray Contrast Activity

Suppliers and Packaging for NDA: 010040

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIATRIZOATE MEGLUMINE	diatrizoate meglumine	INJECTABLE;INJECTION	010040	NDA	BRACCO DIAGNOSTICS INC	0270-0149	0270-0149-57	10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE
RENO-60	diatrizoate meglumine	INJECTABLE;INJECTION	010040	NDA	BRACCO DIAGNOSTICS INC	0270-0149	0270-0149-57	10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	66%;10%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 006

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	52%;8%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 012

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	30%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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