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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208799
Company: TEVA PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AIRDUO DIGIHALER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.055MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Discontinued None Yes No
AIRDUO DIGIHALER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.113MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Discontinued None Yes No
AIRDUO DIGIHALER FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.232MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Discontinued None Yes No
AIRDUO RESPICLICK FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.055MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Prescription None Yes No
AIRDUO RESPICLICK FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.113MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Prescription None Yes No
AIRDUO RESPICLICK FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 0.232MG/INH;EQ 0.014MG BASE/INH POWDER;INHALATION Prescription None Yes Yes
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 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208799Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208799Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/16/2023 SUPPL-26 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208799Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208799Orig1s026ltr.pdf
07/09/2021 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208799s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208799Orig1s021ltr.pdf
01/27/2022 SUPPL-19 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208799Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208799Orig1s019ltr.pdf
02/21/2020 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208799s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208799Orig1s011ltr.pdf
12/20/2017 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208799Orig1s002ltr.pdf
03/02/2018 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208799s001lbl.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
11/16/2023 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208799Orig1s026lbl.pdf
01/27/2022 SUPPL-19 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208799Orig1s019lbl.pdf
07/09/2021 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208799s021lbl.pdf
02/21/2020 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208799s011lbl.pdf
03/02/2018 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208799s001lbl.pdf
12/20/2017 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s002lbl.pdf
01/27/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208799s000lbl.pdf
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