RETHYMIC
These highlights do not include all the information needed to use RETHYMIC safely and effectively. See full prescribing information for RETHYMIC. RETHYMIC (Allogeneic processed thymus tissue–agdc) For surgical implantation Initial U.S. Approval: 2021
Approved
Approval ID
e0022c28-8cda-4f1e-bcf1-1f440d37ec4a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Sumitomo Pharma America, Inc.
DUNS: 131661746
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
allogenic thymocyte-depleted thymus tissue-agdc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72359-001
Application NumberBLA125685
Product Classification
M
Marketing Category
C73585
G
Generic Name
allogenic thymocyte-depleted thymus tissue-agdc
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (1)
ALLOGENEIC THYMOCYTE-DEPLETED THYMUS TISSUE-AGDCActive
Quantity: 22000 mm in 1 1
Code: XD66YK3YY3
Classification: ACTIB