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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 nine 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 NDA: 010040

Tradename:
DIATRIZOATE MEGLUMINE
Applicant:
Bracco
Ingredient:
diatrizoate meglumine
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength66%;10%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Summary for product number 006

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

Summary 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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