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FDA Drug Application 020937 by LIEBEL-FLARSHEIM

Application Number020937
Application Type New Drug Application
Sponsor ApplicantLIEBEL-FLARSHEIM
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
AP012/8/1999N14267000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 6/9/2006
AP012/8/1999N655000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20937ltr.pdf 12/8/1999
AP012/8/1999N2905000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark.cfm 12/8/1999
AP012/8/1999N4855000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20937_OptiMark_prntlbl.pdf 12/8/1999
AP01/29/2001SCS       
AP01/31/2003S7627003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937s3,20-975s3,20-976s3_OptiMark.cfm 1/29/2004
AP01/31/2003S9290003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Approv.pdf 6/10/2004
AP01/31/2003S9291003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-937S003_OptiMark_Prntlbl.pdf 6/10/2004
AP011/23/2005SCS13160007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020937s007ltr.pdf 11/30/2005
AP08/4/2006SE814623009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020937,020975,020976s009lbl.pdf 8/7/2006
AP08/4/2006SE814634009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020937, 020975, 020976s009LTR.pdf 8/7/2006
AP09/4/2007SLR17750011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020937s011,020976s011,020975s012lbl.pdf 9/6/2007
AP09/4/2007SLR17776011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020937s011, 020976s011, 020975s012ltr.pdf 9/6/2007
AP012/20/2010SLR27317016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020937s016lbl.pdf 12/20/2010
AP012/20/2010SLR27335016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020937s016,020975s017,020976s016ltr.pdf 12/22/2010
AP012/12/2012SCM       
AP05/6/2013SCM       
AP05/21/2013SLR36127021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s021,020975Orig1s022,020976Orig1s022ltr.pdf 5/23/2013
AP05/21/2013SLR36135021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s021,020975s022,020976s022lbl.pdf 5/23/2013
AP08/26/2013SLR36898022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020937Orig1s022, 020975Orig1s023, 020976Orig1s024ltr.pdf 8/27/2013
AP08/26/2013SLR36908022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020937s022lbl.pdf 8/27/2013
AP08/7/2014SLR40183023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020937s023,020975s024,020976s025lbl.pdf 8/8/2014
AP08/7/2014SLR40195023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s023,020975Orig1s024,020976Orig1s025ltr.pdf 8/11/2014
AP011/24/2014SLR41093024   http://www.accessdata.fda.gov/drugsatfda_docs/2014/020937s02420975s2520976s26lbl.pdf 11/26/2014
AP011/24/2014SLR41100024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020937Orig1s024,020975Origs025,020976Orig1s026ltr.pdf 11/26/2014
AP03/14/2016SCM       
AP08/29/2016SLR46933026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020937Orig1s026,020975Orig1s027,020976Orig1s028ltr.pdf 9/1/2016
AP08/29/2016SLR46952026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020937s026,020975s027,020976s028lbl.pdf 9/2/2016




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