REGRANEX
These highlights do not include all the information needed to use REGRANEX gel safely and effectively. See full prescribing information for REGRANEX gel. REGRANEX (becaplermin) gel, for topical use Initial U.S. Approval: 1997
Approved
Approval ID
fd2c7d21-7b07-4ab3-8983-816ab3223771
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2023
Manufacturers
FDA
Smith & Nephew, Inc.
DUNS: 827731451
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
becaplermin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50484-810
Application NumberBLA103691
Product Classification
M
Marketing Category
C73585
G
Generic Name
becaplermin
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (10)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
LYSINE HYDROCHLORIDEInactive
Code: JNJ23Q2COM
Classification: IACT
METACRESOLInactive
Code: GGO4Y809LO
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BECAPLERMINActive
Quantity: 100 ug in 1 g
Code: 1B56C968OA
Classification: ACTIB
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT