Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021814
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APTIVUS TIPRANAVIR 250MG CAPSULE;ORAL Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/18/2020 SUPPL-21 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021814s021,022292s014lbl.pdf
06/18/2020 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021814s021,022292s014lbl.pdf
06/22/2018 SUPPL-18 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021814s018lbl.pdf
06/22/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021814s018lbl.pdf
09/15/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021814s016,022292s009lbl.pdf
03/27/2015 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf
03/27/2015 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf
04/07/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021814s014,022292s007lbl.pdf
02/17/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.pdf
04/05/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021814s011lbl.pdf
08/16/2010 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s009lbl.pdf
04/27/2010 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.pdf
06/19/2009 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021814s006,022292s001lbl.pdf
06/23/2008 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf
10/04/2007 SUPPL-3 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021814s003lbl.pdf
08/11/2006 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf
08/11/2006 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf
06/22/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021814lbl.pdf

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