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FDA Drug Application 019462 by VALEANT PHARMS NORTH

Application Number	019462
Application Type	New Drug Application
Sponsor Applicant	VALEANT PHARMS NORTH
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	10/15/1986	N	5521	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462lbl.pdf	4/30/2003
AP	12/12/1986	SLR
AP	4/1/1987	SLR
AP	10/17/1988	SE1
AP	8/18/1988	SCP
AP	11/23/1988	SLR
AP	8/16/1991	SCM
AP	11/30/1990	SLR
AP	11/30/1990	SLR
AP	12/10/1991	SE1
AP	8/22/1997	SLR
AP	11/30/1990	SLR
AP	3/29/1996	SLR
AP	3/29/1996	SLR
AP	3/17/1995	SCS
AP	3/29/1996	SLR
AP	11/13/1996	SCP
AP	2/6/1996	SCM
AP	1/9/1997	SCS
AP	8/12/1998	SLR
AP	8/22/1997	SLR
AP	11/25/1998	SCM
AP	2/8/1999	SCS
AP	10/8/1998	SLR
AP	3/18/1999	SLR	1207	027	http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19462s27.pdf	3/18/1999
AP	11/27/2000	SLR
AP	4/25/2001	SLR	5447	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19462s29lbl.pdf	4/24/2003
AP	6/6/2002	SE8	3356	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19462s030ltr.pdf	6/6/2002
AP	6/6/2002	SE8	3358	030	http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19462s30lbl.pdf	6/6/2002
AP	6/6/2002	SE8	17184	030	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019462_S030 & 019527_S024 & 020752_S005_Pepcid RPD_AP.pdf	7/9/2007
AP	3/14/2001	SLR	1607	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20752s6ltr.pdf	3/14/2001
AP	4/29/2002	SCS
AP	11/5/2007	SLR	18340	034	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019462s034,019510s031,020249s013lbl.pdf	11/7/2007
AP	11/5/2007	SLR	18355	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019462s034, 019510s031, 020249s013ltr.pdf	11/8/2007
AP	3/23/2010	SLR	25107	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019462s035ltr.pdf	3/25/2010
AP	3/23/2010	SLR	25130	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019462s035lbl.pdf	3/26/2010
AP	6/2/2011	SLR	29021	037	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019462s037ltr.pdf	6/3/2011
AP	6/2/2011	SLR	29031	037	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019462s037lbl.pdf	6/7/2011
AP	2/3/2014	SLR	38464	038	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019462s038lbl.pdf	2/6/2014
AP	2/3/2014	SLR	38479	038	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019462Orig1s038ltr.pdf	2/10/2014

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