Application 021433

Type: NDA
Sponsor: GLAXO GRP LTD

Related Records

Company: GLAXO GRP LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLOVENT HFA	FLUTICASONE PROPIONATE	AEROSOL, METERED;INHALATION	0.22MG/INH	Yes	Yes
002	FLOVENT HFA	FLUTICASONE PROPIONATE	AEROSOL, METERED;INHALATION	0.11MG/INH	Yes	Yes
003	FLOVENT HFA	FLUTICASONE PROPIONATE	AEROSOL, METERED;INHALATION	0.044MG/INH	Yes	Yes

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0173-0718	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0718	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0718	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0718	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0718	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0718	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0718	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0718	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0719	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0719	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0719	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0719	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0719	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0719	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0719	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0719	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0720	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0720	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0720	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0720	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0720	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0720	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0720	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
0173-0720	FLOVENT	fluticasone propionate	GlaxoSmithKline LLC	NDA	Current
50090-0910	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-0910	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-0910	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-0916	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-0916	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-0916	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-0934	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-0934	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-0934	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-0934	FLOVENT	fluticasone propionate	A-S Medication Solutions	NDA	Current
50090-6053	Fluticasone Propionate	fluticasone propionate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-6055	Fluticasone Propionate	fluticasone propionate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
50090-6058	Fluticasone Propionate	fluticasone propionate	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
53002-1294	FLOVENT	fluticasone propionate	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1310	FLOVENT	fluticasone propionate	RPK Pharmaceuticals, Inc.	NDA	Current
53002-1310	FLOVENT	fluticasone propionate	RPK Pharmaceuticals, Inc.	NDA	Current
66993-078	Fluticasone Propionate	fluticasone propionate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-079	Fluticasone Propionate	fluticasone propionate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-080	Fluticasone Propionate	fluticasone propionate	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
68788-6926	FLOVENT	fluticasone propionate	Preferred Pharmaceuticals Inc.	NDA	Current
68788-6926	FLOVENT	fluticasone propionate	Preferred Pharmaceuticals Inc.	NDA	Current
68788-6926	FLOVENT	fluticasone propionate	Preferred Pharmaceuticals Inc.	NDA	Current
68788-6926	FLOVENT	fluticasone propionate	Preferred Pharmaceuticals Inc.	NDA	Current
68788-6926	FLOVENT	fluticasone propionate	Preferred Pharmaceuticals Inc.	NDA	Current
70518-0310	FLOVENT	fluticasone propionate	REMEDYREPACK INC.	NDA	Current

Documents

Document	Submission type	Date
68419	SUPPL	2021-08-19
68409	SUPPL	2021-08-19
57519	SUPPL	2019-02-13
57130	SUPPL	2019-01-08
49039	SUPPL	2017-07-21
49027	SUPPL	2017-07-20
45593	SUPPL	2016-10-07
45508	SUPPL	2016-10-06
15451	SUPPL	2016-08-02
5357	SUPPL	2016-08-01
27759	SUPPL	2014-12-12
36911	SUPPL	2014-12-11
5355	SUPPL	2014-12-03
15450	SUPPL	2014-11-20
5356	SUPPL	2014-11-17
36910	SUPPL	2013-07-23
27758	SUPPL	2013-07-22
36909	SUPPL	2011-08-05
5354	SUPPL	2010-11-08
36908	SUPPL	2010-11-03
36907	SUPPL	2008-07-09
5353	SUPPL	2008-07-02
5352	SUPPL	2006-10-27
36906	SUPPL	2006-10-26
36905	SUPPL	2006-03-03
27756	SUPPL	2006-03-03
27757	SUPPL	2006-01-18
15449	SUPPL	2006-01-05
21651	ORIG	2005-12-06
36904	ORIG	2004-05-27
27755	ORIG	2004-05-26
63520	ORIG	1900-01-01