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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 050299


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NDA 050299 describes NILSTAT, which is a drug marketed by Lederle, Strides Pharma, and Chartwell Molecules, and is included in six NDAs. It is available from one supplier. 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-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
Pharmacology for NDA: 050299
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 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:DISCNDosage:SUSPENSION;ORALStrength100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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