Exelderm
Exelderm
Approved
Approval ID
5b73e83e-8d3c-4d96-b4f6-9f854430add8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2022
Manufacturers
FDA
Journey Medical Corporation
DUNS: 079640860
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sulconazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69489-721
Application NumberNDA018738
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sulconazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 27, 2022
FDA Product Classification
INGREDIENTS (8)
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Poloxamer 407Inactive
Code: TUF2IVW3M2
Classification: IACT
Sulconazole NitrateActive
Quantity: 10 mg in 1 mL
Code: 1T89100D5U
Classification: ACTIB
Polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
Butylated HydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Nitric acidInactive
Code: 411VRN1TV4
Classification: IACT