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
NDC Product Code72143-311
Application NumberNDA018737
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateFebruary 4, 2020
Generic NameSulconazole Nitrate
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