FDA Drug Application 050577 by TEVA PHARMS USA

Application Number	050577
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

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	5/7/1982	N
AP	11/17/1986	SLR
AP	4/22/1988	SLR
AP	8/11/1994	SCS
AP	6/14/1993	SCS
AP	9/27/1994	SCM
AP	6/29/1995	SCS
AP	5/5/1999	SLR
AP	12/30/2002	SLR	6212	014	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50577slr014ltr.pdf	7/30/2003
AP	4/3/2000	SCS
AP	1/22/2003	SLR	4843	016	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50577slr016ltr.pdf	1/22/2003
AP	10/22/2002	SCS
AP	12/4/2012	SCM
AP	12/4/2012	SCM
AP	12/4/2012	SCM
AP	8/9/2013	SCM
AP	12/12/2012	SCM
AP	7/31/2014	SCM
AP	9/23/2014	SCM
AP	1/5/2015	SCM
AP	1/5/2015	SCM

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