Vonjo
These highlights do not include all the information needed to use VONJO safely and effectively. See full prescribing information for VONJO. VONJO™ (pacritinib) capsules, for oral useInitial U.S. Approval: 2022
Approved
Approval ID
4b5ab444-0e1a-4984-99db-76ad11a298ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 7, 2022
Manufacturers
FDA
CTI BioPharma Corp.
DUNS: 788479103
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pacritinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72482-100
Application NumberNDA208712
Product Classification
M
Marketing Category
C73594
G
Generic Name
Pacritinib
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2022
FDA Product Classification
INGREDIENTS (5)
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
PacritinibActive
Quantity: 100 mg in 1 1
Code: G22N65IL3O
Classification: ACTIB
Polyethylene glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT