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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73648-117
Application NumberBLA125706
Product Classification
M
Marketing Category
C73585
G
Generic Name
remestemcel-l-rknd
Product Specifications
Effective DateMarch 3, 2025
FDA Product Classification

remestemcel-l-rknd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73648-118
Application NumberBLA125706
Product Classification
M
Marketing Category
C73585
G
Generic Name
remestemcel-l-rknd
Product Specifications
Effective DateMarch 3, 2025
FDA Product Classification

remestemcel-l-rknd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73648-113
Application NumberBLA125706
Product Classification
M
Marketing Category
C73585
G
Generic Name
remestemcel-l-rknd
Product Specifications
Effective DateMarch 3, 2025
FDA Product Classification

remestemcel-l-rknd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73648-111
Application NumberBLA125706
Product Classification
M
Marketing Category
C73585
G
Generic Name
remestemcel-l-rknd
Product Specifications
Effective DateMarch 3, 2025
FDA Product Classification

remestemcel-l-rknd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73648-115
Application NumberBLA125706
Product Classification
M
Marketing Category
C73585
G
Generic Name
remestemcel-l-rknd
Product Specifications
Effective DateMarch 3, 2025
FDA Product Classification

remestemcel-l-rknd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73648-114
Application NumberBLA125706
Product Classification
M
Marketing Category
C73585
G
Generic Name
remestemcel-l-rknd
Product Specifications
Effective DateMarch 3, 2025
FDA Product Classification

remestemcel-l-rknd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73648-112
Application NumberBLA125706
Product Classification
M
Marketing Category
C73585
G
Generic Name
remestemcel-l-rknd
Product Specifications
Effective DateMarch 3, 2025
FDA Product Classification

remestemcel-l-rknd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code73648-116
Application NumberBLA125706
Product Classification
M
Marketing Category
C73585
G
Generic Name
remestemcel-l-rknd
Product Specifications
Effective DateMarch 3, 2025
FDA Product Classification

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