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FDA Drug Application 020789 by SUNOVION PHARMS INC

Application Number020789
Application Type New Drug Application
Sponsor ApplicantSUNOVION PHARMS INC
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
AP03/27/2000N255000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20789ltr.pdf 3/27/2000
AP03/27/2000N256000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20789lbl.pdf 3/27/2000
AP03/27/2000N2203000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020789_Zonegran.cfm 3/27/2000
AP03/27/2000N23477000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152828.pdf 9/30/2009
AP03/27/2000N31646000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100190.htm 2/3/2012
AP08/22/2003SCM6555001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20789scm001_zonegran_lbl.pdf 8/28/2003
AP08/22/2003SCM6556001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20789scm001ltr.pdf 8/28/2003
AP012/4/2000SCM       
AP011/28/2001SCS       
AP02/6/2002SCM       
AP010/7/2002SLR2200005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20789slr005ltr.pdf 10/7/2002
AP010/7/2002SLR2201005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20789s5lbl.pdf 10/7/2002
AP04/1/2002SCM       
AP05/15/2002SCM       
AP06/13/2002SCS       
AP01/26/2012SLR31582012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020789s012ltr.pdf 1/30/2012
AP01/26/2012SLR31617012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf 1/31/2012
AP011/20/2006SLR15383019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020789s019lbl.pdf 11/22/2006
AP011/20/2006SLR15439019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020789s019ltr.pdf 12/4/2006
AP06/19/2015SLR43094021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020789Orig1s021ltr.pdf 6/22/2015
AP06/19/2015SLR43360021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020789s021lbl.pdf 7/14/2015
AP04/23/2009SLR22391022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf 5/4/2009
AP04/23/2009SLR22553022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf 5/13/2009
AP04/19/2010SLR25311024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf 4/20/2010
AP04/19/2010SLR25325024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020789s024,s026ltr.pdf 4/21/2010
AP04/23/2009SLR22392025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020789s022,s025ltr.pdf 5/4/2009
AP04/23/2009SLR22554025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020789s022s025lbl.pdf 5/13/2009
AP04/19/2010SLR25312026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020789s024lbl.pdf 4/20/2010
AP04/19/2010SLR25326026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020789s024,s026ltr.pdf 4/21/2010
AP05/27/2011SLR28996029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020789s029ltr.pdf 5/31/2011
AP09/23/2011SLR30086030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020789s030ltr.pdf 9/27/2011
AP09/23/2011SLR30123030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020789s030lbl.pdf 9/29/2011
AP010/11/2013SCM       
AP011/12/2015SCM       
AP04/6/2016SLR45610034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020789s034lbl.pdf 4/7/2016
AP04/6/2016SLR45620034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020789Orig1s034ltr.pdf 4/8/2016
AP08/11/2016SCM       




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