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Details for New Drug Application (NDA): 011245

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NDA 011245 describes GASTROGRAFIN, 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 GASTROGRAFIN profile page.

The generic ingredient in GASTROGRAFIN is diatrizoate meglumine; diatrizoate sodium. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

Summary for NDA: 011245

diatrizoate meglumine; diatrizoate sodium

Pharmacology for NDA: 011245

Mechanism of ActionX-Ray Contrast Activity

Suppliers and Packaging for NDA: 011245

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
diatrizoate meglumine; diatrizoate sodium
SOLUTION;ORAL, RECTAL 011245 NDA Bracco Diagnostics Inc 0270-0445 0270-0445-35 24 BOTTLE in 1 BOX (0270-0445-35) > 30 mL in 1 BOTTLE
diatrizoate meglumine; diatrizoate sodium
SOLUTION;ORAL, RECTAL 011245 NDA Bracco Diagnostics Inc 0270-0445 0270-0445-40 12 BOTTLE in 1 BOX (0270-0445-40) > 120 mL in 1 BOTTLE

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORAL, RECTALStrength66%;10%
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

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