Nystatin
Nystatin Ointment, USP 100,000 USP Nystatin Units p er Gram For Topical Use Only. Not For Ophthalmic Use. Rx Only
Approved
Approval ID
8f87de59-33f2-32af-ae17-78bf30fb424d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin Ointment
PRODUCT DETAILS
NDC Product Code0713-0686
Application NumberANDA209114
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateNovember 29, 2023
Generic NameNystatin Ointment
INGREDIENTS (2)
NYSTATINActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT