Back to FDA Applications sponsored by LIEBEL-FLARSHEIM

FDA Drug Application 020976 by LIEBEL-FLARSHEIM

Application Number020976
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
AP012/8/1999N2908000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf 12/8/1999
AP012/8/1999N2909000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark.cfm 12/8/1999
AP012/8/1999N4857000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf 12/8/1999
AP012/8/1999N14269000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 6/9/2006
AP01/29/2001SCS       
AP01/31/2003S7629003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937s3,20-975s3,20-976s3_OptiMark.cfm 1/29/2004
AP01/31/2003S9294003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf 6/10/2004
AP01/31/2003S9295003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Approv.pdf 6/10/2004
AP011/14/2002SCS       
AP011/23/2005SCS13162007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020976s007ltr.pdf 11/30/2005
AP08/4/2006SE814625009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf 8/7/2006
AP08/4/2006SE814636009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975, 020976s009LTR.pdf 8/7/2006
AP09/4/2007SLR17749011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf 9/6/2007
AP09/4/2007SLR17775011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011, 020976s011, 020975s012ltr.pdf 9/6/2007
AP012/20/2010SLR27319016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020976s016lbl.pdf 12/20/2010
AP012/20/2010SLR27337016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,020976s016ltr.pdf 12/22/2010
AP05/21/2013SLR36129022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s021,020975Orig1s022,020976Orig1s022ltr.pdf 5/23/2013
AP05/21/2013SLR36133022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s021,020975s022,020976s022lbl.pdf 5/23/2013
AP08/26/2013SLR36900024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s022,%20020975Orig1s023,%20020976Orig1s024ltr.pdf 8/27/2013
AP08/26/2013SLR36910024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020975s2302976s24lbl.pdf 8/27/2013
AP08/7/2014SLR40181025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s023,020975s024,020976s025lbl.pdf 8/8/2014
AP08/7/2014SLR40197025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s023,020975Orig1s024,020976Orig1s025ltr.pdf 8/11/2014
AP011/24/2014SLR41095026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s02420975s2520976s26lbl.pdf 11/26/2014
AP011/24/2014SLR41102026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975Origs025,020976Orig1s026ltr.pdf 11/26/2014
AP08/29/2016SLR46935028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020937Orig1s026,020975Orig1s027,020976Orig1s028ltr.pdf 9/1/2016
AP08/29/2016SLR46954028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020937s026,020975s027,020976s028lbl.pdf 9/2/2016




Back to FDA Applications sponsored by LIEBEL-FLARSHEIM