Drugs@FDA: FDA-Approved Drugs

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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
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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