Details for New Drug Application (NDA): 050299
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The generic ingredient in NILSTAT is nystatin. There are eight drug master file entries for this compound. Forty-one 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 |
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 | Chartwell RX, LLC | 62135-813 | 62135-813-24 | 2 TRAY in 1 BOX (62135-813-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-813-05) |
NILSTAT | nystatin | SUSPENSION;ORAL | 050299 | NDA | Chartwell RX, LLC | 62135-813 | 62135-813-46 | 60 mL in 1 BOTTLE (62135-813-46) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | 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| SUSPENSION;ORAL | Strength | 100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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: | RLD: | Yes |
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