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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021912
Company: LUPIN
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 AN Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/29/2019 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021912Orig1s032lblrpl.pdf
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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