Revcovi
These highlights do not include all the information needed to use REVCOVI safely and effectively. See full prescribing information for REVCOVI. Initial U.S. Approval: 2018
Approved
Approval ID
8c073f84-cdd0-40e4-b3a9-172687267f28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2022
Manufacturers
FDA
Chiesi USA, Inc.
DUNS: 088084228
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
elapegademase-lvlr
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10122-502
Application NumberBLA761092
Product Classification
M
Marketing Category
C73585
G
Generic Name
elapegademase-lvlr
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 31, 2022
FDA Product Classification
INGREDIENTS (5)
ELAPEGADEMASEActive
Quantity: 1.6 mg in 1 mL
Code: 9R3D3Y0UHS
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT