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FDA Drug Application 019627 by FRESENIUS KABI USA

Application Number019627
Application Type New Drug Application
Sponsor ApplicantFRESENIUS 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 TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/2/1989N16789000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109357.htm 6/18/2007
AP01/18/1991SCP       
AP012/31/1991SE121572002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019627_S002_Diprivan.pdf 1/12/2009
AP01/18/1991SLR       
AP01/18/1991SLR       
AP01/18/1991SLR       
AP03/9/1993SCS       
AP05/9/1994SLR       
AP03/8/1993SE1       
AP02/25/1992SCM       
AP012/11/1992SCM       
AP010/26/1993SE1       
AP010/26/1993SLR       
AP09/7/1994SLR       
AP02/24/1995SCP       
AP05/6/1994SCS       
AP04/21/1995SLR       
AP07/31/1995SCP       
AP06/11/1996SCF17196027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019627_S027_Diprivan_APPROVAL_PACKAGE.pdf 7/9/2007
AP09/11/1997SCS       
AP04/29/1999SLR       
AP09/29/1998SCM       
AP02/4/1999SCM       
AP04/29/1999SCM       
AP02/23/2001SE517252035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019627_S035_DiprivanTOC.cfm 7/9/2007
AP02/23/2001SE51314035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19627S35LTR.pdf 2/23/2001
AP02/23/2001SE51315035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19627S35LBL.pdf 2/23/2001
AP012/7/1999SCM       
AP02/7/2000SCP       
AP010/27/2000SCM       
AP09/3/2002SCS       
AP02/8/2007SLR15820045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019627s045ltr.pdf 2/12/2007
AP02/8/2007SLR15855045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019627s045lbl.pdf 2/21/2007
AP02/8/2007SLR21573045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/019627_S045_DIPRIVAN.pdf 1/12/2009
AP04/14/2008SLR19641046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019627s046ltr.pdf 4/16/2008
AP04/14/2008SLR19708046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019627s046lbl.pdf 4/23/2008
AP05/5/2014SCM       
AP07/9/2013SCM37104060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019627Orig1s060ltr.pdf 9/17/2013
AP07/9/2013SCM37189060   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019627Orig1s060.pdf 9/24/2013
AP07/9/2013SCM38383060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019627s60lbl.pdf 1/28/2014
AP06/8/2014SCM39477062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019627s062lbl.pdf 6/10/2014
AP04/17/2015SCM       




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