Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216579
Company: ASTRAZENECA

Products on NDA 216579

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYMBICORT AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE	0.16MG/INH;0.0048MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes
SYMBICORT AEROSPHERE	BUDESONIDE; FORMOTEROL FUMARATE	0.08MG/INH;0.0048MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216579

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2023	ORIG-1	Approval	Efficacy	STANDARD	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216579s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/216579Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2026	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216579s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216579Orig1s001ltr.pdf

Labels for NDA 216579

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2026	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216579s001lbl.pdf
04/28/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216579s000lbl.pdf