FDA Drug Application 022454 by GE HLTHCARE INC

Application Number	022454
Application Type	New Drug Application
Sponsor Applicant	GE HLTHCARE INC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	1/14/2011	N	27558	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022454s000ltr.pdf	1/20/2011
AP	1/14/2011	N	27892	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022454sOrig1s000TOC.cfm	2/16/2011
AP	1/14/2011	N	27894	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022454sOrig1s000SumR.pdf	2/17/2011
AP	1/14/2011	N	43505	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022454Orig1s000Lbl.pdf	7/28/2015
AP	9/11/2015	SLR	43844	004	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022454Orig1s004ltr.pdf	9/11/2015
AP	9/11/2015	SLR	43845	004	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022454Orig1s004lbl.pdf	9/11/2015
AP	9/11/2015	SLR	43846	004	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022454Orig1s004DHCPletter.pdf	9/11/2015

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