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FDA Drug Application 019627 by FRESENIUS KABI USA

Application Number	019627
Application Type	New Drug Application
Sponsor Applicant	FRESENIUS KABI USA
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	10/2/1989	N	16789	000	http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109357.htm	6/18/2007
AP	1/18/1991	SCP
AP	12/31/1991	SE1	21572	002	http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019627_S002_Diprivan.pdf	1/12/2009
AP	1/18/1991	SLR
AP	1/18/1991	SLR
AP	1/18/1991	SLR
AP	3/9/1993	SCS
AP	5/9/1994	SLR
AP	3/8/1993	SE1
AP	2/25/1992	SCM
AP	12/11/1992	SCM
AP	10/26/1993	SE1
AP	10/26/1993	SLR
AP	9/7/1994	SLR
AP	2/24/1995	SCP
AP	5/6/1994	SCS
AP	4/21/1995	SLR
AP	7/31/1995	SCP
AP	6/11/1996	SCF	17196	027	http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019627_S027_Diprivan_APPROVAL_PACKAGE.pdf	7/9/2007
AP	9/11/1997	SCS
AP	4/29/1999	SLR
AP	9/29/1998	SCM
AP	2/4/1999	SCM
AP	4/29/1999	SCM
AP	2/23/2001	SE5	1314	035	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19627S35LTR.pdf	2/23/2001
AP	2/23/2001	SE5	1315	035	http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf	2/23/2001
AP	2/23/2001	SE5	17252	035	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019627_S035_DiprivanTOC.cfm	7/9/2007
AP	12/7/1999	SCM
AP	2/7/2000	SCP
AP	10/27/2000	SCM
AP	9/3/2002	SCS
AP	2/8/2007	SLR	15820	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019627s045ltr.pdf	2/12/2007
AP	2/8/2007	SLR	15855	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf	2/21/2007
AP	2/8/2007	SLR	21573	045	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019627_S045_DIPRIVAN.pdf	1/12/2009
AP	4/14/2008	SLR	19641	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019627s046ltr.pdf	4/16/2008
AP	4/14/2008	SLR	19708	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf	4/23/2008
AP	5/5/2014	SCM
AP	7/9/2013	SCM	37104	060	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019627Orig1s060ltr.pdf	9/17/2013
AP	7/9/2013	SCM	37189	060	http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019627Orig1s060.pdf	9/24/2013
AP	7/9/2013	SCM	38383	060	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf	1/28/2014
AP	6/8/2014	SCM	39477	062	http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf	6/10/2014
AP	4/17/2015	SCM

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