Nystatin and Triamcinolone
Approved
Approval ID
06237703-b962-4e9b-9851-fc06070ed1a6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin and Triamcinolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2470
Application NumberANDA063305
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin and Triamcinolone
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 10, 2011
FDA Product Classification
INGREDIENTS (4)
TRIAMCINOLONE ACETONIDEActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
NYSTATINActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT