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FDA Drug Application 017422 by EMCURE PHARMS LTD

Application Number	017422
Application Type	New Drug Application
Sponsor Applicant	EMCURE PHARMS LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	3/7/1977	N
AP	12/22/1977	SLR
AP	9/15/1978	SCM
AP	10/9/1979	SCS
AP	10/9/1979	SLR
AP	11/12/1980	SLR
AP	4/3/1984	SCE
AP	2/16/1982	SLR
AP	4/21/1987	SPD
AP	2/10/1983	SCM
AP	2/17/1984	SCS
AP	6/29/1983	SLR
AP	3/13/1984	SCS
AP	8/8/1984	SCS
AP	12/10/1984	SCS
AP	7/11/1986	SLR
AP	5/19/1986	SLR
AP	5/19/1986	SLR
AP	5/19/1986	SLR
AP	3/5/1987	SCM
AP	8/7/1987	SCS
AP	10/26/1987	SLR
AP	1/12/1988	SCS
AP	5/17/1988	SCS
AP	4/19/1989	SCM
AP	9/14/1989	SCS
AP	1/3/1991	SCP
AP	6/13/1991	SCS
AP	12/11/1992	SLR
AP	7/13/1992	SCS
AP	9/10/1997	SLR
AP	2/27/2003	SLR	4260	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17422slr035ltr.pdf	3/10/2003
AP	10/20/2005	SCS	12964	036	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017422s036ltr.pdf	10/25/2005
AP	8/17/2007	SCM	17660	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf	8/21/2007
AP	8/17/2007	SCM	17687	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017422s037ltr.pdf	8/22/2007
AP	8/17/2007	SCM	41703	037	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/017422Orig1s037.pdf	1/28/2015
AP	3/14/2011	SLR	28250	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s038lbl.pdf	3/14/2011
AP	3/14/2011	SLR	28252	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017422s038ltr.pdf	3/16/2011
AP	8/11/2011	SLR	29778	042	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s042lbl.pdf	8/12/2011
AP	8/11/2011	SLR	29788	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017422s042ltr.pdf	8/15/2011
AP	9/18/2013	SCM	43690	045	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/017422Orig1s045.pdf	8/21/2015
AP	10/18/2013	SLR	37518	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017422s046lbl.pdf	10/22/2013
AP	6/13/2014	SCM	43691	047	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/017422Orig1s047.pdf	8/21/2015
AP	11/25/2015	SCM
AP	4/28/2016	SLR	45813	050	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017422Orig1s050ltr.pdf	5/2/2016
AP	4/28/2016	SLR	46344	050	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017422Orig2s050Lbl.pdf	6/17/2016
AP	9/20/2016	SCM
AP	10/6/2016	SCM
AP	9/19/2016	SCM

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