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FDA Drug Application 018422 by PFIZER PHARMS

Application Number	018422
Application Type	New Drug Application
Sponsor Applicant	PFIZER PHARMS
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	12/21/1981	N
AP	5/5/1982	SCS
AP	6/1/1982	SLR
AP	9/26/1983	SCM
AP	8/22/1984	SCS
AP	11/20/1986	SCS
AP	12/20/1985	SCS
AP	12/10/1985	SCM
AP	4/4/1986	SLR
AP	8/26/1987	SCP
AP	11/3/1987	SCS
AP	1/28/1988	SCM
AP	11/3/1987	SCM
AP	2/3/1988	SCS
AP	2/3/1988	SCM
AP	5/25/1988	SCS
AP	1/17/1989	SE1
AP	12/1/1988	SCM
AP	11/15/1988	SCM
AP	6/4/1990	SLR
AP	5/30/1989	SCM
AP	5/30/1989	SCM
AP	1/3/1990	SCM
AP	1/29/1990	SCM
AP	3/16/1992	SLR
AP	12/2/1992	SLR
AP	3/24/1995	SLR
AP	12/3/1998	SLR
AP	3/24/1995	SLR
AP	3/24/1995	SLR
AP	7/18/1997	SCM
AP	8/7/2001	SLR	5236	040	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf	4/14/2003
AP	8/7/2001	SLR	9178	040	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf	6/8/2004
AP	8/7/2001	SLR	5235	041	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18422s40s41lbl.pdf	4/14/2003
AP	8/7/2001	SLR	9179	041	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf	6/8/2004
AP	9/26/2002	SCS
AP	1/15/2003	SLR	4764	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18422slr043ltr.pdf	1/15/2003
AP	3/30/2004	SLR	8312	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18422slr045ltr.pdf	4/7/2004
AP	7/14/2009	SLR	22979	048	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018422s048ltr.pdf	7/17/2009
AP	7/14/2009	SLR	22990	048	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018422s048lbl.pdf	7/17/2009
AP	9/27/2010	SLR	26553	050	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018422s050lbl.pdf	9/27/2010
AP	9/27/2010	SLR	26556	050	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018422s050ltr.pdf	9/29/2010
AP	10/31/2013	SLR	37677	053	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018422s053lbl.pdf	11/1/2013
AP	10/31/2013	SLR	37701	053	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018422Orig1s053ltr.pdf	11/6/2013
AP	11/5/2014	SLR	40955	054	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018422Orig1s054ltr.pdf	11/7/2014
AP	11/5/2014	SLR	40961	054	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018422s054lbl.pdf	11/7/2014
AP	4/6/2016	SLR	45612	055	http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018422s055lbl.pdf	4/7/2016
AP	4/6/2016	SLR	45621	055	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018422Orig1s055ltr.pdf	4/8/2016

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