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FDA Drug Application 020622 by TEVA PHARMS USA

Application Number	020622
Application Type	New Drug Application
Sponsor Applicant	TEVA PHARMS USA
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Standard
Orphan Code	V

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/20/1996	N
AP	11/4/1997	SCS
AP	1/23/1998	SCS
AP	1/23/1998	SCM
AP	7/6/2000	SLR
AP	2/16/1999	SCM
AP	2/25/1999	SCS
AP	8/9/2000	SLR
AP	6/28/1999	SCM
AP	7/6/2000	SLR
AP	7/30/1999	SCS
AP	8/3/1999	SCM
AP	8/4/1999	SCM
AP	8/16/1999	SCM
AP	8/16/1999	SCS
AP	7/12/2001	SLR	5493	015	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20622s15lbl.pdf	4/28/2003
AP	7/12/2001	SLR	16197	015	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020622_S015_COPAXONE_INJECTION_AP.pdf	4/9/2007
AP	9/24/1999	SCM
AP	11/29/1999	SCM
AP	1/25/2001	SCS
AP	2/23/2001	SCM
AP	2/28/2001	SLR
AP	6/12/2001	SLR
AP	2/12/2002	SCF	2564	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622s23ltr.pdf	2/12/2002
AP	3/11/2002	SCM
AP	5/20/2002	SCM
AP	8/29/2002	SLR	2563	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622slr026ltr.pdf	8/29/2002
AP	2/27/2009	SE1	21933	057	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020622s057ltr.pdf	3/3/2009
AP	2/27/2009	SE1	22039	057	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf	3/17/2009
AP	2/22/2013	SCM
AP	9/5/2013	SCM
AP	9/5/2013	SCM
AP	3/8/2013	SCM	35431	087	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020622s087lbl.pdf	3/12/2013
AP	1/28/2014	SE8	38397	089	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020622Orig1s089ltr.pdf	1/29/2014
AP	1/28/2014	SE8	38416	089	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020622s089lbl.pdf	1/31/2014
AP	12/6/2013	SCM
AP	1/26/2015	SCM
AP	3/14/2016	SCM
AP	8/3/2015	SCM
AP	12/3/2015	SCM
AP	10/2/2015	SCM
AP	10/24/2016	SCM

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