U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 208798
Company: TEVA PHARM
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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
Back to Top