Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 214070
Company: ASTRAZENECA

Products on NDA 214070

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AIRSUPRA	ALBUTEROL SULFATE; BUDESONIDE	EQ 0.09MG BASE/INH;0.08MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 214070

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/10/2023	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214070s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214070Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214070Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2025	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214070s001lblCorrected.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214070Orig1s001correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214070Orig1s001correctedltr.pdf

Labels for NDA 214070

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2025	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214070s001lblCorrected.pdf
09/15/2025	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214070Orig1s001correctedlbl.pdf
01/10/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214070s000lbl.pdf