Application 021319

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AVODART	DUTASTERIDE	CAPSULE;ORAL	0.5MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0712	AVODART	dutasteride	GlaxoSmithKline LLC	NDA	Current
0173-0712	AVODART	dutasteride	GlaxoSmithKline LLC	NDA	Current
0173-0712	AVODART	dutasteride	GlaxoSmithKline LLC	NDA	Current
0173-0712	AVODART	dutasteride	GlaxoSmithKline LLC	NDA	Current
69784-712	AVODART	dutasteride	Woodward Pharma Services LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61767	SUPPL	2020-02-04
61751	SUPPL	2020-01-31
27474	SUPPL	2013-05-02
27473	SUPPL	2013-05-02
15185	SUPPL	2013-05-01
15184	SUPPL	2013-05-01
27472	SUPPL	2012-06-29
36649	SUPPL	2012-06-28
44115	ORIG	2011-12-20
36648	SUPPL	2011-06-10
27471	SUPPL	2011-06-10
15183	SUPPL	2011-06-10
5024	SUPPL	2011-06-10
27470	SUPPL	2010-09-13
36647	SUPPL	2010-09-10
36646	SUPPL	2010-06-24
5023	SUPPL	2010-06-18
24192	SUPPL	2008-07-17
15181	SUPPL	2008-06-26
5021	SUPPL	2008-06-23
5022	SUPPL	2008-04-02
15182	SUPPL	2008-04-01
27469	SUPPL	2006-01-06
27468	SUPPL	2004-09-15
15180	SUPPL	2004-09-15
15179	SUPPL	2004-08-06
5020	SUPPL	2004-08-06
27467	SUPPL	2004-03-19
36645	SUPPL	2002-10-09
5019	SUPPL	2002-10-09
36644	ORIG	2001-11-20
21596	ORIG	2001-11-20
5018	ORIG	2001-11-20