Details for New Drug Application (NDA): 050576
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NDA 050576 describes NILSTAT, which is a drug marketed by Lederle, Strides Pharma Intl, and Chartwell Molecules, and is included in six NDAs. It is available from two suppliers. Additional details are available on the NILSTAT profile page.
The generic ingredient in NILSTAT is nystatin. There are eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the nystatin profile page.
The generic ingredient in NILSTAT is nystatin. There are eight drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the nystatin profile page.
Summary for 050576
| Tradename: | NILSTAT |
| Applicant: | Strides Pharma Intl |
| Ingredient: | nystatin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050576
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;ORAL | Strength | 100% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 22, 1983 | TE: | RLD: | Yes | |||||
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