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FDA Drug Application 021747 by BOEHRINGER INGELHEIM

Application Number	021747
Application Type	New Drug Application
Sponsor Applicant	BOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	10/7/2011	N	30249	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021747s000ltr.pdf	10/12/2011
AP	10/7/2011	N	30286	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021747s000lbl.pdf	10/12/2011
AP	10/7/2011	N	33482	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021747_combivent_toc.cfm	8/16/2012
AP	10/7/2011	N	33483	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021747Orig1s000SumR.pdf	8/16/2012
AP	8/29/2012	SLR	33605	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021747Orig1s001ltr.pdf	8/31/2012
AP	8/29/2012	SLR	33616	001	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021747s001lbl.pdf	8/31/2012
AP	1/9/2013	SCM
AP	8/14/2014	SCM
AP	6/19/2014	SCM
AP	10/17/2014	SLR	40845	005	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf	10/21/2014
AP	10/17/2014	SLR	40855	005	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021747Orig1s005ltr.pdf	10/22/2014
AP	3/9/2015	SCM
AP	7/9/2015	SCM
AP	1/29/2016	SLR	45062	010	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s010ltr.pdf	2/1/2016
AP	1/29/2016	SLR	45274	010	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s010lbl.pdf	2/25/2016
AP	4/15/2016	SCM
AP	6/9/2016	SLR	46284	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s013ltr.pdf	6/10/2016
AP	6/9/2016	SLR	46308	013	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s013lbl.pdf	6/13/2016
AP	6/17/2016	SCM

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