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FDA Drug Application 021630 by PF PRISM CV

Application Number	021630
Application Type	New Drug Application
Sponsor Applicant	PF PRISM CV
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	12/19/2003	N	7422	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21630ltr.pdf	12/24/2003
AP	12/19/2003	N	7440	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21630_vfend_lb.pdf	12/29/2003
AP	12/19/2003	N	14533	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021630s000_VfendTOC.cfm	7/25/2006
AP	4/21/2004	SLR	8416	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf	4/29/2004
AP	4/21/2004	SLR	8501	001	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf	5/4/2004
AP	4/21/2004	SLR	15637	001	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm	1/10/2007
AP	12/21/2004	SE1	10823	003	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266s009,21267s009,21630s003ltr.pdf	12/29/2004
AP	12/21/2004	SE1	10840	003	http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf	12/29/2004
AP	12/21/2004	SE1	34355	003	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021630Orig1s003.pdf	11/9/2012
AP	3/24/2005	SLR	11297	004	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21266s010,21267s010,21630s004ltr.pdf	3/29/2005
AP	3/24/2005	SLR	11307	004	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf	3/29/2005
AP	7/7/2005	SLR	11970	005	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf	7/8/2005
AP	7/7/2005	SLR	12008	005	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,021267s011ltr.pdf	7/15/2005
AP	12/18/2005	SLR	13342	006	http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf	1/5/2006
AP	12/18/2005	SLR	13415	006	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,021630s006ltr.pdf	1/19/2006
AP	3/10/2006	SLR	13782	008	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021630s008,021267s015,021266s015ltr.pdf	3/22/2006
AP	3/10/2006	SLR	13783	008	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf	3/22/2006
AP	2/5/2008	SLR	19077	009	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021630s009ltr.pdf	2/7/2008
AP	2/5/2008	SLR	19128	009	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf	2/14/2008
AP	5/19/2006	SLR	14146	010	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf	5/22/2006
AP	5/19/2006	SLR	14155	010	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,021630s010LTR .pdf	5/22/2006
AP	12/1/2006	SLR	15408	011	http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf	12/4/2006
AP	12/1/2006	SLR	15570	011	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s019, 021267s021, 021630s011ltr.pdf	12/28/2006
AP	3/10/2008	SLR	19433	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023, 021267s024, 021630s013ltr.pdf	3/13/2008
AP	3/10/2008	SLR	19436	013	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf	3/13/2008
AP	6/17/2010	SLR	25790	014	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf	6/24/2010
AP	6/17/2010	SLR	25815	014	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf	6/24/2010
AP	5/30/2008	SLR	19917	015	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026, 021267s026, 021630s015ltr.pdf	6/3/2008
AP	6/17/2010	SLR	25791	018	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf	6/24/2010
AP	6/17/2010	SLR	25816	018	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf	6/24/2010
AP	6/17/2010	SLR	25792	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf	6/24/2010
AP	6/17/2010	SLR	25817	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf	6/24/2010
AP	6/17/2010	SLR	25793	021	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf	6/24/2010
AP	6/17/2010	SLR	25818	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf	6/24/2010
AP	12/15/2010	SLR	27309	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,021630s022ltr.pdf	12/21/2010
AP	12/15/2010	SLR	27388	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf	12/26/2010
AP	11/21/2010	SLR	27096	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf	11/30/2010
AP	11/21/2010	SLR	27221	023	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021630s023lbl.pdf	11/21/2010
AP	6/1/2011	SLR	29015	024	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,021630s024ltr.pdf	6/2/2011
AP	6/1/2011	SLR	29185	024	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf	6/16/2011
AP	11/16/2011	SLR	30663	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021266s035,021267s040,021630s026ltr.pdf	11/21/2011
AP	11/16/2011	SLR	30700	026	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf	11/21/2011
AP	4/7/2014	SLR	38995	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267Orig1s044,021630Orig1s027ltr.pdf	4/8/2014
AP	4/7/2014	SLR	39006	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf	4/8/2014
AP	2/3/2015	SLR	41784	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021266Orig1s038,021267Orig1s047,021630Orig1s028ltr.pdf	2/5/2015
AP	2/3/2015	SLR	41790	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf	2/5/2015

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