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FDA Drug Application 020184 by SYMPLMED PHARMS LLC

Application Number020184
Application Type New Drug Application
Sponsor ApplicantSYMPLMED PHARMS LLC
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
AP012/30/1993N14278000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm102981.htm 6/9/2006
AP05/13/1994SCM       
AP011/14/1996SCM       
AP01/8/1997SLR3663003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020184ap.pdf 1/8/1997
AP07/21/1997SLR       
AP08/21/1997SCM       
AP08/12/1999SCM       
AP08/14/2002SCM       
AP011/20/2002SCM       
AP010/29/2003SLR6954009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20184slr009ltr.pdf 11/25/2003
AP010/29/2003SLR19584009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020184_S009_ACEON.pdf 4/2/2008
AP08/23/2005SE112675011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020184s011ltr.pdf 8/31/2005
AP08/23/2005SE112690011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020184s011lbl.pdf 8/31/2005
AP09/3/2008SLR20738013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020184s013, s014ltr.pdf 9/4/2008
AP09/3/2008SLR20739014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020184s013, s014ltr.pdf 9/4/2008
AP012/10/2010SLR27363015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020184s015lbl.pdf 12/23/2010
AP012/10/2010SLR27390015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020184s015ltr.pdf 12/28/2010
AP08/23/2011SLR29889017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020184s017ltr.pdf 8/26/2011
AP08/23/2011SLR29946017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020184s017lbl.pdf 9/2/2011
AP04/11/2012SLR32430019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020184s019ltr.pdf 4/13/2012
AP04/11/2012SLR32442019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020184s019lbl.pdf 4/17/2012
AP02/26/2013SLR35276020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020184Orig1s020ltr_replace.pdf 2/28/2013
AP02/26/2013SLR35317020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020184s020lblupdated.pdf 3/1/2013
AP03/30/2015SLR42364022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020184s022lbl.pdf 4/1/2015
AP03/30/2015SLR42370022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020184Orig1s022ltr.pdf 4/2/2015




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