SULFAMYLON
Approved
Approval ID
008eaa23-8f19-4e39-85ff-540c1c834a9e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 3, 2023
Manufacturers
FDA
Rising Pharma Holdings, Inc.
DUNS: 116880195
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
mafenide acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16571-723
Application NumberNDA016763
Product Classification
M
Marketing Category
C73594
G
Generic Name
mafenide acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (11)
MAFENIDE ACETATEActive
Quantity: 85 mg in 1 g
Code: RQ6LP6Z0WY
Classification: ACTIM
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9I
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PEG-8 STEARATEInactive
Code: 2P9L47VI5E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3C
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT