Application 103691

Type: BLA
Sponsor: SMITH AND NEPHEW

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REGRANEX	BECAPLERMIN	GEL; TOPICAL	100UG/G	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50484-810	REGRANEX	becaplermin	Smith & Nephew, Inc.	BLA	Current
50484-810	REGRANEX	becaplermin	Smith & Nephew, Inc.	BLA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
59857	SUPPL	2019-08-27
59856	SUPPL	2019-08-27
59847	SUPPL	2019-08-27
56803	SUPPL	2018-12-19
56609	SUPPL	2018-11-30
56608	SUPPL	2018-11-30
9410	SUPPL	2012-05-03
43274	SUPPL	2012-02-14
39669	SUPPL	2011-03-21
18601	SUPPL	2009-10-02
31607	SUPPL	2008-10-23
39668	SUPPL	2005-05-20
9409	SUPPL	2005-05-20
43273	ORIG	2004-03-11
31606	ORIG	2004-03-11
23941	ORIG	2004-03-11
18600	ORIG	2004-03-11