Sulconazole Nitrate
SULCONAZOLE NITRATEtopical solution 1.0%
Approved
Approval ID
cf6f4340-940c-4a61-b675-456e3297d810
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2021
Manufacturers
FDA
JG Pharma Inc.
DUNS: 081048334
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 Code72143-321
Application NumberNDA018738
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sulconazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJanuary 15, 2021
FDA Product Classification
INGREDIENTS (8)
Sulconazole NitrateActive
Quantity: 10 mg in 1 mL
Code: 1T89100D5U
Classification: ACTIB
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Poloxamer 407Inactive
Code: TUF2IVW3M2
Classification: IACT
Nitric acidInactive
Code: 411VRN1TV4
Classification: IACT
Polysorbate 20Inactive
Code: 7T1F30V5YH
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Butylated HydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT