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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 010040


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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
Formulation / Manufacturing:see details
Pharmacology for NDA: 010040
Mechanism of ActionX-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:DISCNDosage:INJECTABLE;INJECTIONStrength66%;10%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength52%;8%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 012

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength30%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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