FDA.reportPublic FDA data

Application 208798

Type
NDA
Sponsor
TEVA PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARMONAIR RESPICLICKFLUTICASONE PROPIONATEPOWDER;INHALATION0.055MG/INHYesNo
002ARMONAIR RESPICLICKFLUTICASONE PROPIONATEPOWDER;INHALATION0.113MG/INHYesNo
003ARMONAIR RESPICLICKFLUTICASONE PROPIONATEPOWDER;INHALATION0.232MG/INHYesNo
004ARMONAIR DIGIHALERFLUTICASONE PROPIONATEPOWDER;INHALATION0.055MG/INHYesNo
005ARMONAIR DIGIHALERFLUTICASONE PROPIONATEPOWDER;INHALATION0.113MG/INHYesNo
006ARMONAIR DIGIHALERFLUTICASONE PROPIONATEPOWDER;INHALATION0.232MG/INHYesYes
007ARMONAIR RESPICLICKFLUTICASONE PROPIONATEPOWDER;INHALATION0.03MG/INHYesNo
008ARMONAIR DIGIHALERFLUTICASONE PROPIONATEPOWDER;INHALATION0.03MG/INHYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59310-114ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-114ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-114ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-200ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-200ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-200ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-311ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-311ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-311ArmonAir DigihalerFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-505ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-505ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-505ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-515ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-515ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-515ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-525ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-525ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-525ArmonAir Digihalerfluticasone propionateTeva Respiratory, LLCNDACurrent
59310-705ArmonAir RespiClickFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-711ArmonAir RespiClickFluticasone PropionateTeva Respiratory, LLCNDACurrent
59310-722ArmonAir RespiClickFluticasone PropionateTeva Respiratory, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76631SUPPL 2023-11-20
76623SUPPL 2023-11-17
70748SUPPL2022-04-11
70741SUPPL2022-04-11
68060SUPPL2021-07-13
68047SUPPL2021-07-12
64628SUPPL2020-09-21
64621SUPPL2020-09-21
53013SUPPL2018-03-15
52821SUPPL2018-03-06
48046ORIG2017-04-14
47041ORIG2017-01-31
47034ORIG2017-01-27
51124ORIG1900-01-01
51123ORIG1900-01-01
51122ORIG1900-01-01