Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021730
Company: SUNOVION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XOPENEX HFA LEVALBUTEROL TARTRATE EQ 0.045MG BASE/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
03/11/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21730lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21730ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021730s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/27/2017 SUPPL-39 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021730s039lbl.pdf
01/22/2016 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/12/2015 SUPPL-36 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021730s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021730Orig1s036ltr.pdf
08/27/2014 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/25/2013 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/10/2013 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021730s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021730Orig1s033ltr.pdf
03/14/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/09/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/07/2012 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/30/2012 SUPPL-24 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021730s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021730Orig1s024ltr.pdf
02/05/2008 SUPPL-8 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021730s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021730s008ltr.pdf
04/04/2006 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s006ltr.pdf
09/15/2006 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/27/2017 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021730s039lbl.pdf
03/12/2015 SUPPL-36 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021730s036lbl.pdf
09/10/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021730s033lbl.pdf
07/30/2012 SUPPL-24 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021730s024lbl.pdf
02/05/2008 SUPPL-8 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021730s008lbl.pdf
02/05/2008 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021730s008lbl.pdf
03/11/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21730lbl.pdf

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