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FDA Drug Application 022145 by MERCK SHARP DOHME

Application Number	022145
Application Type	New Drug Application
Sponsor Applicant	MERCK SHARP DOHME
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New molecular entity (NME)
Therapeutic Potential	Priority
Orphan Code

Action Type	Duplicate Counter	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	0	10/12/2007	N	18242	000	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022145lbl.pdf	10/15/2007
AP	0	10/12/2007	N	18283	000	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022145s000tr.pdf	10/22/2007
AP	0	10/12/2007	N	19253	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_Isentress.cfm	2/22/2008
AP	0	10/12/2007	N	19254	000	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022145_SumR.pdf	2/22/2008
AP	0	1/30/2009	SE7	21716	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001ltr.pdf	2/3/2009
AP	0	1/30/2009	SE7	21791	001	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s001lbl.pdf	2/4/2009
AP	0	1/30/2009	SE7	21796	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001altr.pdf	2/9/2009
AP	1	1/29/2009	SLR	21716	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001ltr.pdf	2/3/2009
AP	1	1/29/2009	SLR	21791	001	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s001lbl.pdf	2/4/2009
AP	1	1/29/2009	SLR	21796	001	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s001altr.pdf	2/9/2009
AP	0	10/24/2008	SLR	21093	003	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022145s003ltr.pdf	10/28/2008
AP	0	10/24/2008	SLR	21195	003	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022145s003lbl.pdf	11/7/2008
AP	0	7/8/2009	SE5	22918	004	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s004lbl.pdf	7/9/2009
AP	0	7/8/2009	SE5	22969	004	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s004ltr.pdf	7/15/2009
AP	0	7/8/2009	SE5	32421	004	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022145Orig1s004.pdf	4/13/2012
AP	0	1/13/2009	SLR	21631	006	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s006ltr.pdf	1/14/2009
AP	0	1/13/2009	SLR	21636	006	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s006lbl.pdf	1/14/2009
AP	0	6/29/2010	SE8	25901	011	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s011,s012ltr.pdf	7/2/2010
AP	0	6/29/2010	SE8	25919	011	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf	7/6/2010
AP	0	6/29/2010	SE8	25902	012	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s011,s012ltr.pdf	7/2/2010
AP	0	6/29/2010	SE8	25920	012	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s011s012lbl.pdf	7/6/2010
AP	0	11/4/2009	SLR	24094	013	http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022145s013lbl.pdf	11/23/2009
AP	0	11/4/2009	SLR	24563	013	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022145s013ltr.pdf	1/20/2010
AP	0	3/26/2010	SLR	25181	014	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022145s014ltr.pdf	4/2/2010
AP	0	3/26/2010	SLR	25202	014	http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022145s014lbl.pdf	4/4/2010
AP	0	6/10/2011	SLR	29214	015	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf	6/17/2011
AP	0	2/24/2011	SLR	27994	017	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s017ltr.pdf	3/1/2011
AP	0	2/24/2011	SLR	28050	017	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s017lbl.pdf	3/4/2011
AP	0	4/11/2011	SLR	28526	018	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s018lbl.pdf	4/11/2011
AP	0	4/11/2011	SLR	28538	018	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s018ltr.pdf	4/13/2011
AP	0	11/2/2011	SLR	30524	020	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s020ltr.pdf	11/7/2011
AP	0	11/2/2011	SLR	30634	020	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s020lbl.pdf	11/16/2011
AP	0	3/28/2012	SE8	32263	021	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s021,203045s001lbl.pdf	3/28/2012
AP	0	3/28/2012	SE8	32324	021	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s021,0203045s001ltr.pdf	4/2/2012
AP	0	12/21/2011	SE5	31228	022	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022145s022lbl.pdf	12/23/2011
AP	0	12/21/2011	SE5	31274	022	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022145s022ltr.pdf	12/28/2011
AP	0	4/18/2012	SE8	32494	023	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022145s023,203045s002lbl.pdf	4/20/2012
AP	0	4/18/2012	SE8	32503	023	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145s023,203045s002ltr.pdf	4/23/2012
AP	0	8/10/2012	SLR	33438	026	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022145Orig1s026,203045Orig1s003ltr.pdf	8/15/2012
AP	0	8/10/2012	SLR	33476	026	http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203045s003,022145s026lbl.pdf	8/15/2012
AP	0	6/28/2013	SE8	36429	027	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s027,203045Orig1s004ltr_replace.pdf	7/2/2013
AP	0	6/28/2013	SE8	36444	027	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s027,203045s004lbl.pdf	7/3/2013
AP	0	4/4/2013	SLR	35652	028	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s028,203045s005lbl.pdf	4/9/2013
AP	0	4/4/2013	SLR	35665	028	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s028,203045Orig1s005ltr.pdf	4/9/2013
AP	0	8/5/2013	SLR	36697	029	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022145s029lbl.pdf	8/5/2013
AP	0	8/5/2013	SLR	36710	029	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s029,203045Orig1s007ltr.pdf	8/6/2013
AP	0	10/24/2013	SLR	37561	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022145Orig1s030,203045Orig1s008ltr.pdf	10/25/2013
AP	0	12/20/2013	SE8	38137	031	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205786s000,022145s031,203045s009lbl.pdf	12/23/2013
AP	0	12/20/2013	SE8	38199	031	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205786Orig1s000,022145Orig1s031,203045Orig1s009ltr.pdf	12/31/2013
AP	0	4/8/2014	SLR	39020	032	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022145Orig1s032,203045Orig1s010,205786Orig1s001ltr.pdf	4/10/2014
AP	0	4/8/2014	SLR	39029	032	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022145s032,203045s010,205786s001lbl.pdf	4/10/2014
AP	0	10/10/2014	SCM
AP	0	2/18/2015	SLR	41876	034	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s002,203045Orig1s011,022145Orig1s034ltr.pdf	2/19/2015
AP	0	2/18/2015	SLR	41886	034	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s034l,203045s011,205786s002lbl.pdf	2/20/2015
AP	0	2/20/2015	SLR	41895	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022145s035,203045s012,205786s003lbl.pdf	2/23/2015
AP	0	2/20/2015	SLR	41911	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205786Orig1s003,203045Orig1s012,022145Orig1s035ltr.pdf	2/24/2015

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