Sulconazole Nitrate
SULCONAZOLE NITRATEcream 1.0%
Approved
Approval ID
5b731aa0-fb3f-4a96-9034-636138cbca03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2020
Manufacturers
FDA
JG Pharma
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 Code72143-311
Application NumberNDA018737
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sulconazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 4, 2020
FDA Product Classification
INGREDIENTS (13)
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Sulconazole NitrateActive
Quantity: 10 mg in 1 g
Code: 1T89100D5U
Classification: ACTIB
Stearyl alcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Glyceryl monostearateInactive
Code: 230OU9XXE4
Classification: IACT
Isopropyl myristateInactive
Code: 0RE8K4LNJS
Classification: IACT
Cetyl alcoholInactive
Code: 936JST6JCN
Classification: IACT
Sorbitan monostearateInactive
Code: NVZ4I0H58X
Classification: IACT
Polysorbate 60Inactive
Code: CAL22UVI4M
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
PEG-100 stearateInactive
Code: YD01N1999R
Classification: IACT
Ascorbyl palmitateInactive
Code: QN83US2B0N
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Nitric acidInactive
Code: 411VRN1TV4
Classification: IACT