MedPath
FDA Approval

Ketoconazole

May 13, 2019

HUMAN PRESCRIPTION DRUG LABEL

Ketoconazole(20 mg in 1 g)

Products (1)

Ketoconazole

16714-955

ANDA075638

ANDA (C73584)

TOPICAL

May 13, 2019

butylated hydroxyanisoleInactive
Code: REK4960K2UClass: IACT
cetyl alcoholInactive
Code: 936JST6JCNClass: IACT
isopropyl myristateInactive
Code: 0RE8K4LNJSClass: IACT
polysorbate 60Inactive
Code: CAL22UVI4MClass: IACT
sorbitan monostearateInactive
Code: NVZ4I0H58XClass: IACT
stearyl alcoholInactive
Code: 2KR89I4H1YClass: IACT
Code: R9400W927IClass: ACTIBQuantity: 20 mg in 1 g
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
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