Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022292
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APTIVUS TIPRANAVIR 100MG/ML SOLUTION;ORAL 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
06/23/2008 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021814s005, 022292s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005, 022292_aptivus_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021814s005,%2022-292s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021814s016,022292s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021814Orig1s016,022292Orig1s009ltr.pdf
03/27/2015 SUPPL-8 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021814Orig1s015,022292Orig1s008ltr.pdf
04/07/2014 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021814s014,022292s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021814Origs014,022292Orig1s007ltr.pdf
02/17/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021814s013,022292s006ltr.pdf
04/05/2011 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022292s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021814s011,022292s004ltr.pdf
08/16/2010 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022292s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s009,022292s003ltr.pdf
04/27/2010 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s008,022292s002ltr.pdf
06/19/2009 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021814s006,022292s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021814s006,022292s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/15/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021814s016,022292s009lbl.pdf
03/27/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf
03/27/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021814s015,022292s008lbl.pdf
04/07/2014 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021814s014,022292s007lbl.pdf
02/17/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021814s013,022292s006lbl.pdf
04/05/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022292s004lbl.pdf
08/16/2010 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022292s003lbl.pdf
04/27/2010 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s008,022292s002lbl.pdf
06/19/2009 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021814s006,022292s001lbl.pdf
06/23/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021814s005,022292lbl.pdf

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