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Serving leading biopharmaceutical companies globally:

Harvard Business School

Generated: January 23, 2018

DrugPatentWatch Database Preview

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 two suppliers. 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. Three suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.
Summary for 011245
Ingredient:diatrizoate meglumine; diatrizoate sodium
Formulation / Manufacturing:see details
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
GASTROGRAFIN 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
GASTROGRAFIN 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

Profile 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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Serving leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Express Scripts
Cantor Fitzgerald

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