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FDA Approval

Ketoconazole

CompanyNuCare Pharmaceuticals,Inc. (DUNS: 010632300)

Effective Date

December 13, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ketoconazole(200 mg in 1 1)

Manufacturing Establishments (1)

NuCare Pharmaceuticals,Inc.

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

Products (1)

Ketoconazole

NDC Product Code

68071-2902

Application Number

ANDA075319

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 13, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

KetoconazoleActive

Code: R9400W927IClass: ACTIBQuantity: 200 mg in 1 1

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT

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