Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021929
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYMBICORT BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE 0.08MG/INH;0.0045MG/INH AEROSOL, METERED;INHALATION Prescription None Yes Yes
SYMBICORT BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE 0.16MG/INH;0.0045MG/INH AEROSOL, 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
07/21/2006 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021929lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021929ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021929_symbicort_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2017 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021929Orig1s042ltr.pdf
09/11/2017 SUPPL-41 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021929Orig1s041ltr.pdf
06/10/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

06/28/2014 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/14/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

04/04/2014 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/27/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/15/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

07/23/2012 SUPPL-33 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021929Orig1s033ltr.pdf
05/08/2012 SUPPL-30 Labeling-Medication Guide

Label is not available on this site.

08/18/2011 SUPPL-28 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021929s028ltr.pdf
06/25/2010 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021929s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021929s021ltr.pdf
02/16/2011 SUPPL-19 REMS-Assessment, REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021929s019ltr.pdf
01/27/2017 SUPPL-13 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021929Orig1s013ltr.pdf
02/27/2009 SUPPL-12 Efficacy-New Indication, REMS-Proposal Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021929s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021929s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021929Orig1s012.pdf
07/16/2008 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021929s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021929s010ltr.pdf
10/26/2007 SUPPL-6 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021929s006ltr.pdf
10/31/2007 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021929s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2017 SUPPL-42 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s042lbl.pdf
09/11/2017 SUPPL-41 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s041lbl.pdf
01/27/2017 SUPPL-13 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021929s013lbl.pdf
06/25/2010 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021929s021lbl.pdf
02/27/2009 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021929s012lbl.pdf
02/27/2009 SUPPL-12 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021929s012lbl.pdf
07/16/2008 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021929s010lbl.pdf
10/31/2007 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s004lbl.pdf
10/26/2007 SUPPL-6 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021929s006lbl.pdf
07/21/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021929lbl.pdf

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