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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208798
Company: TEVA PHARM

Products on NDA 208798

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.055MG/INH	POWDER;INHALATION	Prescription	None	Yes	No
ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.113MG/INH	POWDER;INHALATION	Prescription	None	Yes	No
ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.232MG/INH	POWDER;INHALATION	Prescription	None	Yes	Yes
ARMONAIR DIGIHALER	FLUTICASONE PROPIONATE	0.03MG/INH	POWDER;INHALATION	Discontinued	None	Yes	No
ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.055MG/INH	POWDER;INHALATION	Discontinued	None	Yes	No
ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.113MG/INH	POWDER;INHALATION	Discontinued	None	Yes	No
ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.232MG/INH	POWDER;INHALATION	Discontinued	None	Yes	No
ARMONAIR RESPICLICK	FLUTICASONE PROPIONATE	0.03MG/INH	POWDER;INHALATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208798

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/27/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208798s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208798Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208798Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2023	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208798Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208798Orig1s016ltr.pdf
04/08/2022	SUPPL-13	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208798s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208798Orig1s013ltr.pdf
01/27/2022	SUPPL-10	Labeling-Container/Carton Labels		Label is not available on this site.
07/09/2021	SUPPL-8	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208798s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208798Orig1s008ltr.pdf
09/18/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208798s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208798Orig1s007ltr.pdf
03/02/2018	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208798s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208798Orig1s002,208799Orig1s001ltr.pdf

Labels for NDA 208798

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/16/2023	SUPPL-16	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208798Orig1s016lbl.pdf
04/08/2022	SUPPL-13	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208798s013lbl.pdf
07/09/2021	SUPPL-8	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208798s008lbl.pdf
09/18/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208798s007lbl.pdf
03/02/2018	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208798s002lbl.pdf
01/27/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208798s000lbl.pdf

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