Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021912
Company: SUNOVION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BROVANA ARFORMOTEROL TARTRATE EQ 0.015MG BASE/2ML SOLUTION;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
10/06/2006 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021912s000tr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912_brovana_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021912s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/12/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

07/11/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

11/06/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

09/16/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/11/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/25/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/27/2014 SUPPL-23 Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021912Orig1s023ltr.pdf
02/26/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

01/14/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/09/2012 SUPPL-20 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf
08/09/2012 SUPPL-18 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021912Orig1s018,s020ltr.pdf
09/02/2011 SUPPL-16 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s016ltr.pdf
02/16/2011 SUPPL-15 Labeling, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s015ltr.pdf
02/01/2011 SUPPL-12 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s012ltr.pdf
06/02/2010 SUPPL-11 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021912s011ltr.pdf
06/22/2010 SUPPL-8 Labeling-Medication Guide

Label is not available on this site.

07/14/2011 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021912s006ltr.pdf
12/20/2007 SUPPL-1 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021912s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/27/2014 SUPPL-23 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf
02/27/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021912s013lbl.pdf
07/14/2011 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s006lbl.pdf
02/16/2011 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf
02/16/2011 SUPPL-15 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021912s015lbl.pdf
06/02/2010 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021912s011lbl.pdf
12/20/2007 SUPPL-1 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021912s001lbl.pdf
10/06/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021912lbl.pdf

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