Nystatin and Triamcinolone Acetonide
Nystatin and Triamcinolone Acetonide Cream
Approved
Approval ID
44a37f35-e533-4b09-bbcf-97ffaff1920b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2021
Manufacturers
FDA
Glenmark Pharmaceuticals Inc., USA
DUNS: 130597813
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin and Triamcinolone Acetonide
PRODUCT DETAILS
NDC Product Code68462-314
Application NumberANDA208136
Marketing CategoryC73584
Route of AdministrationTOPICAL
Effective DateJanuary 31, 2021
Generic NameNystatin and Triamcinolone Acetonide
INGREDIENTS (15)
NystatinActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
Triamcinolone AcetonideActive
Quantity: 1 mg in 1 g
Code: F446C597KA
Classification: ACTIB
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT