Details for New Drug Application (NDA): 080059
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NDA 080059 describes NEOPASALATE, which is a drug marketed by Medpointe Pharm Hlc and is included in one NDA. Additional details are available on the NEOPASALATE profile page.
The generic ingredient in NEOPASALATE is aminosalicylate sodium; aminosalicylic acid. There are three drug master file entries for this compound. Additional details are available on the aminosalicylate sodium; aminosalicylic acid profile page.
The generic ingredient in NEOPASALATE is aminosalicylate sodium; aminosalicylic acid. There are three drug master file entries for this compound. Additional details are available on the aminosalicylate sodium; aminosalicylic acid profile page.
Summary for 080059
| Tradename: | NEOPASALATE |
| Applicant: | Medpointe Pharm Hlc |
| Ingredient: | aminosalicylate sodium; aminosalicylic acid |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 846MG;112MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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