Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Aurinia Pharma U.S., Inc.
117485579
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LUPKYNIS
Product Details
NDC Product Code
75626-001Application Number
NDA213716Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 13, 2023ALCOHOLInactive
Code: 3K9958V90MClass: IACT
POLYSORBATE 40Inactive
Code: STI11B5A2XClass: IACT
TOCOPHERSOLANInactive
Code: O03S90U1F2Class: IACT
VoclosporinActive
Code: 2PN063X6B1Class: ACTIBQuantity: 7.9 mg in 1 1
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT