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FDA Drug Application 019430 by MYLAN SPECLT

Application Number	019430
Application Type	New Drug Application
Sponsor Applicant	MYLAN SPECLT
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New manufacturer
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/22/1987	N
AP	3/2/1989	SLR
AP	8/3/1995	SCS
AP	7/25/1996	SCS
AP	1/24/1997	SCM
AP	5/25/1999	SCM
AP	12/15/1999	SCM
AP	11/5/1999	SCM
AP	5/11/2000	SCM
AP	1/11/2001	SCS
AP	8/27/2001	SLR	5288	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19430s12lbl.pdf	4/15/2003
AP	2/20/2002	SCS
AP	4/16/2002	SCE
AP	6/28/2002	SCM
AP	8/21/2002	SCS
AP	12/19/2002	SCS
AP	12/17/2003	SLR	7294	025	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19430slr025ltr.pdf	12/22/2003
AP	9/26/2008	SLR	20904	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019430s044ltr.pdf	10/1/2008
AP	9/26/2008	SLR	20932	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019430s044lbl.pdf	10/3/2008
AP	5/19/2009	SLR	22622	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019430s047ltr.pdf	5/26/2009
AP	8/20/2012	SLR	33534	053	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf	8/20/2012
AP	8/20/2012	SLR	33535	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019430Orig1s053ltr.pdf	8/22/2012
AP	7/23/2013	SCM	38281	054	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s054.pdf	1/15/2014
AP	9/16/2013	SCM	38288	055	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s055.pdf	1/16/2014
AP	11/8/2013	SCM	38289	056	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s056.pdf	1/16/2014
AP	12/13/2013	SCM
AP	7/17/2014	SLR	39903	058	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430orig1s058ltr.pdf	7/21/2014
AP	7/17/2014	SLR	40067	058	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/19430Orig1s058lbl.pdf	7/30/2014
AP	4/30/2014	SLR	39191	059	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430Orig1s059ltr.pdf	5/1/2014
AP	4/30/2014	SLR	39201	059	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019430s059lbl.pdf	5/2/2014
AP	3/3/2016	SCM
AP	5/18/2016	SLR	46073	061	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019430Orig1s061ltr.pdf	5/20/2016
AP	5/18/2016	SLR	46086	061	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019430s061lbl.pdf	5/20/2016
AP	8/15/2016	SCM

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