FDA.reportPublic FDA data

Application 208799

Type
NDA
Sponsor
TEVA PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AIRDUO RESPICLICKFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.055MG/INH;EQ 0.014MG BASE/INHYesNo
002AIRDUO RESPICLICKFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.113MG/INH;EQ 0.014MG BASE/INHYesNo
003AIRDUO RESPICLICKFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.232MG/INH;EQ 0.014MG BASE/INHYesYes
004AIRDUO DIGIHALERFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.055MG/INH;EQ 0.014MG BASE/INHYesNo
005AIRDUO DIGIHALERFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.113MG/INH;EQ 0.014MG BASE/INHYesNo
006AIRDUO DIGIHALERFLUTICASONE PROPIONATE; SALMETEROL XINAFOATEPOWDER;INHALATION0.232MG/INH;EQ 0.014MG BASE/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3607Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3608Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
0093-3609Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolTeva Pharmaceuticals USA, Inc.NDA AUTHORIZED GENERICCurrent
50090-3271Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3271Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3271Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED Current
50090-3272Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3272Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3272Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED Current
50090-3387Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3387Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3387Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3387Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3387Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3387Fluticasone Propionate and SalmeterolFluticasone Propionate and SalmeterolA-S Medication SolutionsNDA AUTHORIZED Current
59310-111AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-111AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-111AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-111AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-111AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-129AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-129AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-129AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-129AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-129AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-136AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-136AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-136AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-136AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-136AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-510AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-510AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-510AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-510AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-510AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-520AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-520AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-520AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-520AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-520AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-530AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-530AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-530AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-530AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-530AirDuo DigihalerFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-805AirDuo RespiClickFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-805AirDuo RespiClickFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-805AirDuo RespiClickFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-805AirDuo RespiClickFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-805AirDuo RespiClickFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-805AirDuo RespiClickFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-805AirDuo RespiClickFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent
59310-805AirDuo RespiClickFluticasone Propionate and SalmeterolTeva Respiratory, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76630SUPPL 2023-11-20
76624SUPPL 2023-11-17
70550SUPPL2022-03-17
70452SUPPL2022-03-10
68059SUPPL2021-07-13
68049SUPPL2021-07-12
61980SUPPL2020-02-27
61957SUPPL2020-02-25
52915SUPPL2018-03-12
52822SUPPL2018-03-06
50880SUPPL2017-12-27
50843SUPPL2017-12-22
48045ORIG2017-04-14
47040ORIG2017-01-31
47035ORIG2017-01-27
51128ORIG1900-01-01
51127ORIG1900-01-01
51126ORIG1900-01-01