FDA.reportPublic FDA data

Application 103691

Type
BLA
Sponsor
SMITH AND NEPHEW

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103691Regranexbecaplermin351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REGRANEXBECAPLERMINGEL; TOPICAL100UG/GNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regranex Gel 0.01%BECAPLERMIN GEL 0.01%LRM Therapeutics, LLC377b3021-13d7-96d5-e063-6394a90a8ca32026-05-08Warnings, Adverse reactionsExact identifier
application number: BLA103691

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50484-810REGRANEXbecaplerminSmith & Nephew, Inc.BLACurrent
50484-810REGRANEXbecaplerminSmith & Nephew, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59857SUPPL2019-08-27
59856SUPPL2019-08-27
59847SUPPL2019-08-27
56803SUPPL2018-12-19
56609SUPPL2018-11-30
56608SUPPL2018-11-30
9410SUPPL2012-05-03
43274SUPPL2012-02-14
39669SUPPL2011-03-21
18601SUPPL2009-10-02
31607SUPPL2008-10-23
39668SUPPL2005-05-20
9409SUPPL2005-05-20
43273ORIG2004-03-11
31606ORIG2004-03-11
23941ORIG2004-03-11
18600ORIG2004-03-11