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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208799
Company: TEVA PHARM

Products on NDA 208799

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	Prescription	None	Yes	No
AIRDUO DIGIHALER	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.113MG/INH;EQ 0.014MG BASE/INH	POWDER;INHALATION	Prescription	None	Yes	No
AIRDUO DIGIHALER	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE	0.232MG/INH;EQ 0.014MG BASE/INH	POWDER;INHALATION	Prescription	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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208799

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

Labels for NDA 208799

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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