MedPath
FDA Approval

REGRANEX

December 11, 2023

HUMAN PRESCRIPTION DRUG LABEL

Becaplermin(100 ug in 1 g)

Registrants (1)

Smith & Nephew, Inc.

827731451

Manufacturing Establishments (1)

Smith & Nephew Wound Management

Smith & Nephew, Inc.

Smith & Nephew, Inc.

125458849

Products (1)

REGRANEX

50484-810

BLA103691

BLA (C73585)

TOPICAL

December 11, 2023

ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
LYSINE HYDROCHLORIDEInactive
Code: JNJ23Q2COMClass: IACT
METACRESOLInactive
Code: GGO4Y809LOClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 1B56C968OAClass: ACTIBQuantity: 100 ug in 1 g
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
© Copyright 2025. All Rights Reserved by MedPath