FDA Drug Application 021057 by ORGANON USA INC

Application Number	021057
Application Type	New Drug Application
Sponsor Applicant	ORGANON USA 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	7/29/1999	N	1065	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21057ltr.pdf	7/29/1999
AP	7/29/1999	N	1066	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21057lbl.pdf	7/29/1999
AP	7/29/1999	N	8748	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21057_Antagon.cfm	5/27/2004
AP	6/7/2001	SCS
AP	5/15/2001	SLR
AP	12/20/2002	SCS
AP	6/30/2008	SLR	20109	007	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021057s007lbl.pdf	6/30/2008
AP	6/30/2008	SLR	20152	007	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021057s007ltr.pdf	7/2/2008
AP	3/10/2016	SCM
AP	12/19/2014	SLR	41369	010	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021057Orig1s010ltr.pdf	12/23/2014
AP	12/19/2014	SLR	41588	010	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021057s010lbl.pdf	1/9/2015
AP	1/12/2015	SCM
AP	5/3/2016	SCM
AP	8/2/2016	SCM

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