FDA Drug Application 020221 by CLINIGEN HLTHCARE

Application Number	020221
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	V

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/8/1995	N
AP	1/23/1996	SCS
AP	3/15/1996	SE1
AP	12/30/1996	SCS
AP	11/21/1996	SCM
AP	12/18/1996	SCM
AP	2/20/1997	SCS
AP	10/10/1997	SCM
AP	3/11/1999	SLR
AP	2/11/1999	SCS
AP	6/24/1999	SE1	1174	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20221s12ltr.pdf	6/24/1999
AP	6/24/1999	SE1	1175	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20221s12lbl.pdf	6/24/1999
AP	6/24/1999	SE1	1815	012	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20221-S012_Ethyol.cfm	6/24/1999
AP	4/1/1999	SLR
AP	9/10/1999	SCS
AP	2/20/2002	SLR	1814	015	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20221s15ltr.pdf	2/20/2002
AP	3/27/2003	SLR	4654	017	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20221slr017_ethyol_lbl.pdf	3/28/2003
AP	3/27/2003	SLR	5277	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20221slr017ltr.pdf	4/15/2003
AP	3/28/2006	SLR	13850	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020221s020ltr.pdf	4/5/2006
AP	11/7/2008	SLR	21208	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020221s024lbl.pdf	11/12/2008
AP	11/7/2008	SLR	21222	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020221s024ltr.pdf	11/13/2008
AP	8/26/2013	SCM
AP	3/9/2016	SCM
AP	1/15/2016	SCM

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