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FDA Approval

Korsuva

CompanyVifor (International) Inc. (DUNS: 482603065)

Effective Date

January 30, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Difelikefalin acetate(50 ug in 1 mL)

Manufacturing Establishments (3)

Patheon Manufacturing Services LLC

Labeler

Vifor (International) Inc.

DUNS Number

079415560

Patheon Italia S.p.A

Labeler

Vifor (International) Inc.

DUNS Number

338336589

Siegfried Hameln GmbH

Labeler

Vifor (International) Inc.

DUNS Number

315869123

Products (1)

Korsuva

NDC Product Code

59353-065

Application Number

NDA214916

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

January 30, 2024

Ingredients

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACT

Difelikefalin acetateActive

Code: 0P70AR5BYBClass: ACTIMQuantity: 50 ug in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

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