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FDA Drug Application 050758 by ROCHE PALO

Application Number	050758
Application Type	New Drug Application
Sponsor Applicant	ROCHE PALO
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 Title	Document URL	Document Date
AP	8/12/1998	N	576	000		http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/505758.cfm	8/12/1998
AP	8/12/1998	N	22951	000		http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm	7/15/2009
AP	8/12/1998	N	23631	000		http://www.fda.gov/downloads/Drugs/DrugSafety/UCM170919.pdf	10/19/2009
AP	8/12/1998	N	33855	000	REMS	http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37	9/27/2012
AP	4/20/2000	SCM
AP	6/16/2000	SCS
AP	7/27/2000	SLR	10376	003		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722s004_50-723s003_50-758s003_50-759s004_CellCept.cfm	10/8/2004
AP	7/28/2000	SE1	2366	004		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/50759S6LTR.PDF	7/28/2000
AP	7/28/2000	SE1	2367	004		http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/50722005LBL.PDF	7/28/2000
AP	7/28/2000	SE1	2368	004		http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-722S005_CellCept.cfm	7/28/2000
AP	2/28/2003	SLR	3841	005		http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050759s008lbl.pdf	2/28/2003
AP	2/28/2003	SLR	4250	005		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50759slr008,50758slr005,50723slr006,50722slr008ltr.pdf	3/10/2003
AP	2/27/2002	SCS
AP	12/17/2002	SCM
AP	4/12/2005	SLR	11433	010		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050758s010lbl.pdf	4/19/2005
AP	4/12/2005	SLR	11434	010		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050758s010ltr.pdf	4/19/2005
AP	10/17/2005	SLR	12892	012		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050722s013,050723s010,050758s012,050759s015ltr.pdf	10/19/2005
AP	10/17/2005	SLR	12905	012		http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050722s013,050723s010,050758s012,050759s015lbl.pdf	10/19/2005
AP	12/20/2007	SLR	18670	013		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s015,050723s012,050758s013,050759s018lbl.pdf	12/27/2007
AP	12/20/2007	SLR	18772	013		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s015,050723s012,050758s013,050759s018ltr.pdf	1/9/2008
AP	9/21/2007	SLR	17992	014		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050722s16,50723s13,50758s14,50759s19ltr.pdf	9/25/2007
AP	9/21/2007	SLR	18027	014		http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050722s16,50723s13,50758s14,50759s19lbl.pdf	9/26/2007
AP	5/9/2008	SLR	19838	016		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s018_050723s015_050758s016_050759s021ltr.pdf	5/15/2008
AP	5/9/2008	SLR	19842	016		http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050758s016lbl.pdf	5/16/2008
AP	12/15/2008	SLR	21400	017		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050722s019, 050723s017, 050758s017, 050759s022ltr.pdf	12/24/2008
AP	12/15/2008	SLR	21469	017		http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050722s19,050723s17,050758s17,050759s22lbl.pdf	1/2/2009
AP	2/27/2009	SLR	21948	018		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s020,050723s018,050758s018,050759s023ltr.pdf	3/5/2009
AP	2/27/2009	SLR	22055	018		http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s020,050723s018,050758s018,050759s023lbl.pdf	3/19/2009
AP	6/18/2009	SLR	22809	019		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s021,050723s019,050758s019,050759s024ltr.pdf	6/23/2009
AP	6/18/2009	SLR	22825	019		http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s021,050723s019,050758s019,050759s024lbl.pdf	6/24/2009
AP	9/25/2012	SLR	33865	020		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722Orig1s022,050723Orig1s020,050758Orig1s020,050759Orig1s025ltr.pdf	9/27/2012
AP	10/8/2009	SLR	23587	022		http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050722s024,050723s023,050758s022,050759s028lbl.pdf	10/14/2009
AP	10/8/2009	SLR	23761	022		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050722s024,059723s023,050758s022,050759s028ltr.pdf	11/9/2009
AP	6/8/2012	SLR	32898	024		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s026,050723s025,050758s024,050759s031ltr.pdf	6/12/2012
AP	6/8/2012	SLR	32937	024		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031lbl.pdf	6/18/2012
AP	6/8/2012	SLR	32938	024		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s026,050723s025,050758s024,050759s031mg.pdf	6/18/2012
AP	2/14/2013	SCM
AP	6/22/2012	SLR	32997	026		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050722s028,050723s027,050758s026,050759s033ltr.pdf	6/26/2012
AP	6/22/2012	SLR	33015	026		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033mg.pdf	6/26/2012
AP	6/22/2012	SLR	33016	026		http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050722s028,050723s027,050758s026,050759s033lbl.pdf	6/26/2012
AP	9/27/2013	SLR	37288	028		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf	10/1/2013
AP	9/27/2013	SLR	37304	028		http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf	10/1/2013
AP	9/27/2013	SLR	37289	029		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050722Orig1s030,s031,050723Orig1s029,s030,050758Orig1s028,s029,050759Orig1s036,s037ltr.pdf	10/1/2013
AP	9/27/2013	SLR	37305	029		http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050722s030s031,050723s029s030,050758s028s029,.pdf	10/1/2013
AP	7/9/2015	SLR	43337	030		http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050722s033,050723s032,050758s030,050759s038lbl.pdf	7/13/2015
AP	7/9/2015	SLR	43358	030		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s033,050723Orig1s032,050758Orig1s030,050759Orig1s038ltr.pdf	7/14/2015
AP	11/13/2015	S	44523	031		http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050722Orig1s034,050723Orig1s033,050758Orig1s031,050759Orig1s040ltr.pdf	11/19/2015
AP	5/26/2016	SCM

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