Details for New Drug Application (NDA): 011245
✉ Email this page to a colleague
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 eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.
The generic ingredient in GASTROGRAFIN is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.
Summary for 011245
| Tradename: | GASTROGRAFIN |
| Applicant: | Bracco |
| Ingredient: | diatrizoate meglumine; diatrizoate sodium |
| Patents: | 0 |
Pharmacology for NDA: 011245
| Mechanism of Action | X-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: | RX | Dosage: | SOLUTION;ORAL, RECTAL | Strength | 66%;10% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes | ||||
Complete Access Available with Subscription
