TAVNEOS
These highlights do not include all the information needed to use TAVNEOS safely and effectively. See full prescribing information for TAVNEOS. TAVNEOS (avacopan) capsules, for oral use Initial U.S. Approval: 2021
Approved
Approval ID
c93cbc0b-29a3-46a5-9c85-41815ea5cf4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2022
Manufacturers
FDA
ChemoCentryx, Inc.
DUNS: 002356900
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
avacopan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73556-168
Application NumberNDA214487
Product Classification
M
Marketing Category
C73594
G
Generic Name
avacopan
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2022
FDA Product Classification
INGREDIENTS (9)
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AVACOPANActive
Quantity: 10 mg in 1 1
Code: O880NM097T
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT