MedPath
FDA Approval

Ketoconazole

October 31, 2022

HUMAN PRESCRIPTION DRUG LABEL

Ketoconazole(20 mg in 1 mL)

Products (1)

Ketoconazole

45802-465

ANDA076419

ANDA (C73584)

TOPICAL

February 21, 2017

Code: R9400W927IClass: ACTIBQuantity: 20 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
COCO DIETHANOLAMIDEInactive
Code: 92005F972DClass: IACT
DISODIUM LAURETH SULFOSUCCINATEInactive
Code: D6DH1DTN7EClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
IMIDUREAInactive
Code: M629807ATLClass: IACT
PEG-120 METHYL GLUCOSE DIOLEATEInactive
Code: YM0K64F20VClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM LAURETH-3 SULFATEInactive
Code: BPV390UAP0Class: IACT

Drug Labeling Information

SPL UNCLASSIFIED SECTION

Manufactured By Padagis

Yeruham, Israel

Distributed By

Padagis

Allegan, MI 49010

www.padagis.com

4L926RCF6

Rev 10-22


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