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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021949
Company: ASTRAZENECA

Products on NDA 021949

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PULMICORT FLEXHALER	BUDESONIDE	0.08MG/INH	POWDER, METERED;INHALATION	Prescription	None	Yes	No
PULMICORT FLEXHALER	BUDESONIDE	0.16MG/INH	POWDER, METERED;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021949

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2006	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021949lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021949s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021949_budesonide_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2019	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021949s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021949Orig1s013ltr.pdf
06/17/2016	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/16/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/02/2010	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021949s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021949s006ltr.pdf
06/13/2008	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021949s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021949s004ltr.pdf
04/11/2008	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021949s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021949s003ltr.pdf
06/21/2007	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021949s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021949s002ltr.pdf
02/16/2007	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021949s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021949s001ltr.pdf

Labels for NDA 021949

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/06/2019	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021949s013lbl.pdf
07/02/2010	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021949s006lbl.pdf
06/13/2008	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021949s004lbl.pdf
04/11/2008	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021949s003lbl.pdf
06/21/2007	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021949s002lbl.pdf
02/16/2007	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021949s001lbl.pdf
07/12/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021949lbl.pdf

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