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FDA Approval

KETOCONAZOLE

CompanyNuCare Pharmaceuticals,Inc. (DUNS: 010632300)

Effective Date

March 17, 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

66267-400

Application Number

ANDA210457

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 17, 2022

Ingredients

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

KetoconazoleActive

Code: R9400W927IClass: ACTIBQuantity: 200 mg in 1 1

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