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FDA Drug Application 019516 by PURDUE PHARMA LP

Application Number	019516
Application Type	New Drug Application
Sponsor Applicant	PURDUE PHARMA LP
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Priority
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document Title	Document URL	Document Date
AP	5/29/1987	N	33135	000		http://www.fda.gov/downloads/Drugs/DrugSafety/UCM311374.pdf	7/11/2012
AP	5/29/1987	N	33136	000	REMS	http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17	7/11/2012
AP	4/8/1988	SCS
AP	9/12/1989	SCS
AP	1/16/1990	SCS
AP	11/8/1993	SCS
AP	5/2/1988	SCS
AP	4/12/1990	SCF
AP	4/29/1997	SCM
AP	5/12/2000	SCS
AP	5/2/2000	SCM
AP	5/2/2000	SCM
AP	5/2/2000	SCM
AP	5/2/2000	SCM
AP	6/27/2000	SCM
AP	5/2/2000	SCM
AP	2/12/2001	SLR
AP	12/18/2001	SLR
AP	2/21/2003	SCP	9239	019		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19516scp019ltr.pdf	6/9/2004
AP	8/6/2003	SLR	6487	021		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19516slr021ltr.pdf	8/14/2003
AP	5/11/2007	S	16613	030		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019516s030ltr.pdf	5/29/2007
AP	5/11/2010	SLR	25547	034		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019516s034ltr.pdf	5/14/2010
AP	5/11/2010	SLR	25570	034		http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019516s034lbl.pdf	5/17/2010
AP	7/9/2012	SLR	33138	036		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019516Orig1s036ltr.pdf	7/11/2012
AP	7/9/2012	SLR	33158	036		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s036lbl.pdf	7/12/2012
AP	7/9/2012	SLR	33148	037		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019516Orig1s037ltr.pdf	7/11/2012
AP	7/9/2012	SLR	33184	037		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s037lbl.pdf	7/13/2012
AP	4/15/2013	SLR	35715	038		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019516Orig1s038ltr.pdf	4/16/2013
AP	6/2/2014	SCM
AP	4/16/2014	SLR	39069	042		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf	4/16/2014
AP	4/16/2014	SLR	39078	042		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s042ltr.pdf	4/17/2014
AP	10/22/2014	SLR	40897	043		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s043,022272Orig1s023ltr.pdf	10/30/2014
AP	10/22/2014	SLR	40901	043		http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516Orig1s043lbl.pdf	10/30/2014
AP	8/19/2014	S	40279	044		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s044ltr.pdf	8/20/2014
AP	6/26/2015	S	43134	046		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019516Orig1s046ltr.pdf	6/29/2015
AP	4/20/2016	S	45715	047		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s047ltr.pdf	4/22/2016
AP	9/21/2016	SCM
AP	9/30/2016	S	47263	050		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019516Orig1s050ltr.pdf	10/4/2016

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