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FDA Drug Application 020975 by LIEBEL-FLARSHEIM

Application Number020975
Application Type New Drug Application
Sponsor ApplicantLIEBEL-FLARSHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/8/1999N2906000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf 12/8/1999
AP012/8/1999N2907000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark.cfm 12/8/1999
AP012/8/1999N4856000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf 12/8/1999
AP012/8/1999N14268000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 6/9/2006
AP01/29/2001SCS       
AP01/31/2003S7628003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937s3,20-975s3,20-976s3_OptiMark.cfm 1/29/2004
AP01/31/2003S9292003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Approv.pdf 6/10/2004
AP01/31/2003S9293003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf 6/10/2004
AP011/23/2005SCS13161007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020975s007ltr.pdf 11/30/2005
AP08/4/2006SE814624009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf 8/7/2006
AP08/4/2006SE814635009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975, 020976s009LTR.pdf 8/7/2006
AP08/15/2008SLR20648010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020975s010ltr.pdf 8/20/2008
AP08/15/2008SLR20673010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020975s010lbl.pdf 8/26/2008
AP09/4/2007SLR17748012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf 9/6/2007
AP09/4/2007SLR17774012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011, 020976s011, 020975s012ltr.pdf 9/6/2007
AP012/20/2010SLR27318017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020975s017lbl.pdf 12/20/2010
AP012/20/2010SLR27336017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,020976s016ltr.pdf 12/22/2010
AP05/21/2013SLR36128022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020975s022ltr.pdf020937Orig1s021,020975Orig1s022,020976Orig1s022ltr.pdf 5/23/2013
AP05/21/2013SLR36134022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s021,020975s022,020976s022lbl.pdf 5/23/2013
AP08/26/2013SLR36899023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s022,%20020975Orig1s023,%20020976Orig1s024ltr.pdf 8/27/2013
AP08/26/2013SLR36909023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020975s2302976s24lbl.pdf 8/27/2013
AP08/7/2014SLR40182024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s023,020975s024,020976s025lbl.pdf 8/8/2014
AP08/7/2014SLR40196024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s023,020975Orig1s024,020976Orig1s025ltr.pdf 8/11/2014
AP011/24/2014SLR41094025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26lbl.pdf 11/26/2014
AP011/24/2014SLR41101025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975Origs025,020976Orig1s026ltr.pdf 11/26/2014
AP08/29/2016SLR46934027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020937Orig1s026,020975Orig1s027,020976Orig1s028ltr.pdf 9/1/2016
AP08/29/2016SLR46953027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020937s026,020975s027,020976s028lbl.pdf 9/2/2016




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