MedPath
FDA Approval

Ketoconazole Cream

February 7, 2023

HUMAN PRESCRIPTION DRUG LABEL

Ketoconazole(20 mg in 1 g)

Registrants (1)

Direct_Rx

079254320

Manufacturing Establishments (1)

Direct_Rx

Direct_Rx

Direct_Rx

079254320

Products (1)

Ketoconazole Cream

72189-422

ANDA212443

ANDA (C73584)

TOPICAL

February 7, 2023

STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58XClass: IACT
Code: R9400W927IClass: ACTIBQuantity: 20 mg in 1 g
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SODIUM SULFITEInactive
Code: VTK01UQK3GClass: IACT
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