RYONCIL
These highlights do not include all the information needed to use RYONCIL safely and effectively. See full prescribing information for RYONCIL. RYONCIL (remestemcel-L-rknd) suspension for intravenous infusion Initial U.S. Approval: December 2024
Approved
Approval ID
a4e0918f-7444-4694-adeb-d38d98345659
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2025
Manufacturers
FDA
Mesoblast
DUNS: 616697426
Products 8
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
remestemcel-l-rknd
PRODUCT DETAILS
NDC Product Code73648-117
Application NumberBLA125706
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateMarch 3, 2025
Generic Nameremestemcel-l-rknd
remestemcel-l-rknd
PRODUCT DETAILS
NDC Product Code73648-118
Application NumberBLA125706
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateMarch 3, 2025
Generic Nameremestemcel-l-rknd
remestemcel-l-rknd
PRODUCT DETAILS
NDC Product Code73648-113
Application NumberBLA125706
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateMarch 3, 2025
Generic Nameremestemcel-l-rknd
remestemcel-l-rknd
PRODUCT DETAILS
NDC Product Code73648-111
Application NumberBLA125706
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateMarch 3, 2025
Generic Nameremestemcel-l-rknd
remestemcel-l-rknd
PRODUCT DETAILS
NDC Product Code73648-115
Application NumberBLA125706
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateMarch 3, 2025
Generic Nameremestemcel-l-rknd
remestemcel-l-rknd
PRODUCT DETAILS
NDC Product Code73648-114
Application NumberBLA125706
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateMarch 3, 2025
Generic Nameremestemcel-l-rknd
remestemcel-l-rknd
PRODUCT DETAILS
NDC Product Code73648-112
Application NumberBLA125706
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateMarch 3, 2025
Generic Nameremestemcel-l-rknd
remestemcel-l-rknd
PRODUCT DETAILS
NDC Product Code73648-116
Application NumberBLA125706
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateMarch 3, 2025
Generic Nameremestemcel-l-rknd