← FDA DRUG APPROVALS

FDA BLA · BLA103691

REGRANEX GEL 0.01%

becaplermin gel 0.01%

Sponsor: SMITH AND NEPHEW

APPLICATION
BLA103691
TYPE
BLA
ORIGINAL APPROVAL
1997-12-16
LATEST ACTION
2019-08-26
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

REGRANEXPrescription
BECAPLERMIN 100UG/G · GEL · TOPICAL

Approval history

2019-08-26Labeling · Supplement 5138 · standard — Letter ↗AP
2018-11-28Efficacy · Supplement 5134 · standard — Label ↗AP
2012-04-30Labeling · Supplement 5109 · standard — Letter ↗AP
2011-03-11Labeling · Supplement 5095 · standard — Label ↗AP
2010-04-28Labeling · Supplement 5087 · standardAP
2010-04-09Labeling · Supplement 5086 · standardAP
2008-10-16Labeling · Supplement 5074 · standard — Label ↗AP
2005-05-13Efficacy · Supplement 5015 · standard — Label ↗AP
1997-12-16Type 1 - New Molecular Entity · Original · unknown — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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