SYNRIBO
These highlights do not include all the information needed to use SYNRIBO safely and effectively. See full prescribing information for SYNRIBO. SYNRIBO (omacetaxine mepesuccinate) for injection, for subcutaneous useInitial U.S. Approval: 2012
Approved
Approval ID
83a504ef-cf92-467d-9ecf-d251194a3484
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2022
Manufacturers
FDA
Cephalon, LLC
DUNS: 183236314
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Omacetaxine Mepesuccinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63459-177
Application NumberNDA203585
Product Classification
M
Marketing Category
C73594
G
Generic Name
Omacetaxine Mepesuccinate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (2)
OMACETAXINE MEPESUCCINATEActive
Quantity: 3.5 mg in 1 mL
Code: 6FG8041S5B
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT