Details for New Drug Application (NDA): 050299
NDA 050299 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 is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the nystatin profile page.
The generic ingredient in NILSTAT is nystatin. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the nystatin profile page.
Summary for 050299
| Tradename: | NILSTAT |
| Applicant: | Chartwell Molecules |
| Ingredient: | nystatin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050299
Suppliers and Packaging for NDA: 050299
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NILSTAT | nystatin | SUSPENSION;ORAL | 050299 | NDA AUTHORIZED GENERIC | Chartwell RX, LLC | 62135-813 | 62135-813-46 | 60 mL in 1 BOTTLE (62135-813-46) |
| NILSTAT | nystatin | SUSPENSION;ORAL | 050299 | NDA AUTHORIZED GENERIC | Chartwell RX, LLC | 62135-813 | 62135-813-47 | 473 mL in 1 BOTTLE (62135-813-47) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AA | RLD: | Yes | ||||
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