Details for New Drug Application (NDA): 009395
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NDA 009395 describes PASKALIUM, which is a drug marketed by Glenwood and is included in one NDA. Additional details are available on the PASKALIUM profile page.
The generic ingredient in PASKALIUM is potassium aminosalicylate. There is one drug master file entry for this compound. Additional details are available on the potassium aminosalicylate profile page.
The generic ingredient in PASKALIUM is potassium aminosalicylate. There is one drug master file entry for this compound. Additional details are available on the potassium aminosalicylate profile page.
Summary for 009395
| Tradename: | PASKALIUM |
| Applicant: | Glenwood |
| Ingredient: | potassium aminosalicylate |
| Patents: | 0 |
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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