Application 020637

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLIADEL	CARMUSTINE	IMPLANT;INTRACRANIAL	7.7MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24338-050	Gliadel	carmustine	Arbor Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57135	SUPPL	2019-01-08
56651	SUPPL	2018-12-07
2969	SUPPL	2014-11-24
35052	SUPPL	2013-08-21
25414	SUPPL	2013-08-20
20798	ORIG	2013-02-25
2968	SUPPL	2007-01-08
20799	SUPPL	2003-07-08
2967	SUPPL	2003-03-10
35051	SUPPL	2003-03-05