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FDA Approval

Vonjo

CompanyCTI BioPharma Corp. (DUNS: 788479103)

Effective Date

March 7, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pacritinib(100 mg in 1 1)

Manufacturing Establishments (3)

AndersonBrecon Inc.

Labeler

CTI BioPharma Corp.

DUNS Number

053217022

Eurofins Analytics & Services Austria GmbH

Labeler

CTI BioPharma Corp.

DUNS Number

301161092

Evonik Operations GmbH

Labeler

CTI BioPharma Corp.

DUNS Number

343230955

Products (1)

Vonjo

NDC Product Code

72482-100

Application Number

NDA208712

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

March 7, 2022

Ingredients

Microcrystalline celluloseInactive

Code: OP1R32D61UClass: IACT

PacritinibActive

Code: G22N65IL3OClass: ACTIBQuantity: 100 mg in 1 1

Polyethylene glycol 8000Inactive

Code: Q662QK8M3BClass: IACT

Magnesium stearateInactive

Code: 70097M6I30Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

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