Details for New Drug Application (NDA): 087388
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NDA 087388 describes MD-GASTROVIEW, which is a drug marketed by Liebel-flarsheim and is included in one NDA. It is available from one supplier. Additional details are available on the MD-GASTROVIEW profile page.
The generic ingredient in MD-GASTROVIEW 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 MD-GASTROVIEW 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 087388
| Tradename: | MD-GASTROVIEW |
| Applicant: | Liebel-flarsheim |
| Ingredient: | diatrizoate meglumine; diatrizoate sodium |
| Patents: | 0 |
Pharmacology for NDA: 087388
| Mechanism of Action | X-Ray Contrast Activity |
Suppliers and Packaging for NDA: 087388
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MD-GASTROVIEW | diatrizoate meglumine; diatrizoate sodium | SOLUTION;ORAL, RECTAL | 087388 | ANDA | Liebel-Flarsheim Company LLC | 0019-4816 | 0019-4816-04 | 25 BOTTLE, GLASS in 1 BOX (0019-4816-04) / 30 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL, RECTAL | Strength | 66%;10% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | No | ||||
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