FDA Drug Application 020068 by CLINIGEN HLTHCARE

Application Number	020068
Application Type	New Drug Application
Sponsor Applicant	CLINIGEN HLTHCARE
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	9/27/1991	N
AP	12/12/1995	SLR
AP	6/16/1995	SE1
AP	11/17/1995	SLR
AP	1/24/1997	SE1
AP	1/24/1997	SE2
AP	1/24/1997	SLR
AP	3/31/1997	SLR
AP	1/3/1997	SCS
AP	11/16/1998	SCS
AP	6/13/2000	SLR
AP	6/13/2000	SLR
AP	5/15/2006	SLR	14096	016	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020068s016lbl.pdf	5/16/2006
AP	5/15/2006	SLR	14123	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020068s016LTR.pdf	5/18/2006
AP	11/27/2007	SLR	18612	017	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020068s017lbl.pdf	12/3/2007
AP	2/10/2012	SCM	32359	018	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020068s018lbl.pdf	4/6/2012
AP	6/10/2014	SCM
AP	11/7/2014	SLR	40979	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020068Orig1s020ltr.pdf	11/12/2014
AP	11/7/2014	SLR	42732	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf	5/5/2015
AP	5/29/2015	SCM

Back to FDA Applications sponsored by CLINIGEN HLTHCARE