Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021949
Company: ASTRAZENECA
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
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
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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