Nystatin
NYSTATIN TOPICAL POWDER, USP
Approved
Approval ID
9e122c5f-65e4-4c92-aaa0-ae97dd725b1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 19, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nystatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76519-1007
Application NumberANDA065203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nystatin
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 19, 2012
FDA Product Classification
INGREDIENTS (2)
NystatinActive
Quantity: 100000 [USP'U] in 1 g
Code: BDF1O1C72E
Classification: ACTIB
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT