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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021814
Company: BOEHRINGER INGELHEIM

Summary Review

Products on NDA 021814

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APTIVUS	TIPRANAVIR	250MG	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021814

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2005	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021814lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021814ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21814_000_AptivusTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/18/2020	SUPPL-21	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021814s021,022292s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022292Orig1s014,021814Orig1s021ltr.pdf
06/22/2018	SUPPL-18	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021814s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022292Orig1s010,021814Orig1s018ltr.pdf
09/15/2016	SUPPL-16	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-15	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-14	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-13	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-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021814s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021814s011,022292s004ltr.pdf
08/16/2010	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021814s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021814s009,022292s003ltr.pdf
04/27/2010	SUPPL-8	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-6	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
06/23/2008	SUPPL-5	Efficacy-New Indication	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
05/14/2007	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021814s004ltr.pdf
10/04/2007	SUPPL-3	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021814s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021814s003ltr.pdf
08/11/2006	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021814s001, 021814s002LTR.pdf
08/11/2006	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021814s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021814s001, 021814s002LTR.pdf

Labels for NDA 021814

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/18/2020	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021814s021,022292s014lbl.pdf
06/18/2020	SUPPL-21	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021814s021,022292s014lbl.pdf
06/22/2018	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021814s018lbl.pdf
06/22/2018	SUPPL-18	Labeling-Patient 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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