FDA.report

Application 021077

Type
NDA
Sponsor
GLAXO GRP LTD

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ADVAIR DISKUS 100/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.1MG/INH;EQ 0.05MG BASE/INHYesYes
002ADVAIR DISKUS 250/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.25MG/INH;EQ 0.05MG BASE/INHYesYes
003ADVAIR DISKUS 500/50FLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.5MG/INH;EQ 0.05MG BASE/INHYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0695ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0696ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
0173-0697ADVAIRfluticasone propionate and salmeterolGlaxoSmithKline LLCNDACurrent
21695-196ADVAIRfluticasone propionate and salmeterolRebel Distributors Corp.NDACurrent
21695-197ADVAIRfluticasone propionate and salmeterolRebel Distributors Corp.NDACurrent
21695-361ADVAIRfluticasone propionate and salmeterolRebel Distributors CorpNDACurrent
33261-873ADVAIRfluticasone propionate and salmeterolAidarex Pharmaceuticals LLCNDACurrent
33261-874ADVAIRfluticasone propionate and salmeterolAidarex Pharmaceuticals LLCNDACurrent
50090-0730ADVAIRfluticasone propionate and salmeterolA-S Medication SolutionsNDACurrent
50090-0731ADVAIRfluticasone propionate and salmeterolA-S Medication SolutionsNDACurrent
50090-0731ADVAIRfluticasone propionate and salmeterolA-S Medication SolutionsNDACurrent
50090-0732ADVAIRfluticasone propionate and salmeterolA-S Medication SolutionsNDACurrent
50090-4211Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4211Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4211Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4211Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4213Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4213Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4213Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4213Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4214Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4214Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4214Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-4214Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-584Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-585Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
66993-586Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolPrasco LaboratoriesNDA AUTHORIZED GENERICCurrent
68258-3031ADVAIRfluticasone propionate and salmeterolDispensing Solutions Inc.NDACurrent
70518-0508ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0508ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0514ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0514ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0514ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0514ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
70518-0538ADVAIRfluticasone propionate and salmeterolREMEDYREPACK INC.NDACurrent
71205-262Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-262Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolProficient Rx LPNDA AUTHORIZED GENERICCurrent
71205-262Fluticasone Propionate and Salmeterolfluticasone propionate and salmeterolProficient Rx LPNDA AUTHORIZED GENERICCurrent

Documents

DocumentSubmission typeDate
57517SUPPL2019-02-13
57132SUPPL2019-01-08
50882SUPPL2017-12-27
50881SUPPL2017-12-27
50828SUPPL2017-12-21
50827SUPPL2017-12-21
62320SUPPL2017-12-20
62319SUPPL2017-12-20
47493SUPPL2017-03-08
47458SUPPL2017-03-03
44470SUPPL2016-06-23
14304SUPPL2016-05-05
4233SUPPL2016-05-02
41933SUPPL2015-11-18
14303SUPPL2014-12-20
4232SUPPL2014-11-14
44994SUPPL2014-06-17
26660SUPPL2014-04-16
14302SUPPL2014-04-16
21421SUPPL2013-08-06
41932SUPPL2012-10-12
26659SUPPL2012-08-13
4231SUPPL2011-07-05
26658SUPPL2011-05-12
4229SUPPL2011-01-07
4230SUPPL2010-06-29
14301SUPPL2010-06-28
4228SUPPL2009-04-03
21420SUPPL2008-08-01
44636SUPPL2008-07-16
14300SUPPL2008-05-02
26657SUPPL2008-05-01
41931SUPPL2007-09-24
26655SUPPL2007-03-01
14298SUPPL2007-02-26
4227SUPPL2006-10-02
36026SUPPL2006-09-28
26656SUPPL2006-03-23
14299SUPPL2006-03-03
23623ORIG2005-11-30
36025SUPPL2004-10-04
26654SUPPL2004-10-04
36024SUPPL2004-05-04
26652SUPPL2004-04-29
36023SUPPL2003-12-02
26651SUPPL2003-11-25
21419ORIG2003-08-28
26653SUPPL2003-08-15
14297SUPPL2003-08-15
4226SUPPL2002-08-21