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Drug Product Composition: Ketoconazole

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$ API Ref.Price (USD/KG) : 90Xls

USFDA APPLICATION NUMBER - 19927 / DOSAGE - SHAMPOO;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ketoconazole(UNII: R9400W927I)
(ketoconazole - UNII:R9400W927I)
ketoconazole20mg in 1

Inactive Ingredients

Ingredient Name
A-S Medication Solutions LLC
Janssen Pharmaceuticals, Inc.
Patriot Pharmaceuticals, LLC
COCO DIETHANOLAMIDE(92005F972D)
disodium laureth sulfosuccinate(D6DH1DTN7E)
FD&C RED NO. 40(WZB9127XOA)
HYDROCHLORIC ACID(QTT17582CB)
IMIDUREA(M629807ATL)
PEG-120 METHYL GLUCOSE DIOLEATE(YM0K64F20V)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM LAURETH-3 SULFATE(BPV390UAP0)
WATER(059QF0KO0R)