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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103691
Company: SMITH AND NEPHEW

Medication Guide

Other Important Information from FDA

Products on BLA 103691

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
REGRANEX	BECAPLERMIN	100UG/G	GEL; TOPICAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103691

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/1997	ORIG-1	Approval		N/A	Label (PDF) Letter Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/becaomj121697-lab.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/becaomj121697L.htm https://web.archive.org/web/20170113111514/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080740.htm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2019	SUPPL-5138	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103691s5138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103691Orig1s5138ltr.pdf
11/28/2018	SUPPL-5134	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103691s5134lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103691Orig1s5134ltr.pdf
04/30/2012	SUPPL-5109	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103691s5109ltr.pdf
03/11/2011	SUPPL-5095	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103691s5095lbl.pdf
04/28/2010	SUPPL-5087	Supplement		Label is not available on this site.
04/09/2010	SUPPL-5086	Supplement		Label is not available on this site.
10/16/2008	SUPPL-5074	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103691s5074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103691s5074ltr.pdf
05/13/2005	SUPPL-5015	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103691s5015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103691s5015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/103691Orig1s5015Approv.pdf

Labels for BLA 103691

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/2019	SUPPL-5138	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103691s5138lbl.pdf
11/28/2018	SUPPL-5134	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103691s5134lbl.pdf
03/11/2011	SUPPL-5095	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103691s5095lbl.pdf
10/16/2008	SUPPL-5074	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103691s5074lbl.pdf
05/13/2005	SUPPL-5015	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103691s5015lbl.pdf
12/16/1997	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/becaomj121697-lab.pdf

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