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FDA Drug Application 021158 by LG LIFE SCIENCES

Application Number021158
Application Type New Drug Application
Sponsor ApplicantLG LIFE SCIENCES
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
AP04/4/2003N4926000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021158lbl.pdf 4/4/2003
AP04/4/2003N5386000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21158ltr.pdf 4/18/2003
AP04/4/2003N6644000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21158_Factive.cfm 9/24/2003
AP04/4/2003N23993000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152723.pdf 11/19/2009
AP07/25/2003SE16500001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21158se1-001_factive_lbl.pdf 8/15/2003
AP07/25/2003SE16516001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21158se1-001ltr.pdf 8/15/2003
AP07/28/2004SLR9914002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21158s002ltr.pdf 7/30/2004
AP07/28/2004SLR9923002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21158s002lbl.pdf 7/30/2004
AP09/7/2004SLR10170003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21158s003ltr.pdf 9/10/2004
AP09/7/2004SLR10178003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21158s003lbl.pdf 9/10/2004
AP010/26/2006SLR15280005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021158s005lbl.pdf 10/27/2006
AP010/26/2006SLR15320005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021158s005ltr.pdf 11/6/2006
AP05/1/2007SE216431007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021158s007ltr.pdf 5/7/2007
AP05/1/2007SE216450007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021158s007lbl.pdf 5/7/2007
AP012/18/2007SLR18823011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021158s011ltr.pdf 1/9/2008
AP010/3/2008SLR20970012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021158s012ltr.pdf 10/8/2008
AP010/3/2008SLR21004012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s012lbl.pdf 10/9/2008
AP010/29/2008SCP22196013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021158s013lbl.pdf 4/3/2009
AP04/27/2009SLR22417014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021158s014ltr.pdf 5/4/2009
AP04/27/2009SLR22503014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021158s014lbl.pdf 5/11/2009
AP02/25/2011SLR28028018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021158s018ltr.pdf 3/3/2011
AP02/25/2011SLR28073018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021158s018lbl.pdf 3/4/2011
AP010/18/2011SLR30351021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021158s021ltr.pdf 10/20/2011
AP010/18/2011SLR30385021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021158s021lbl.pdf 10/20/2011
AP08/14/2013SLR36798022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021158s022lbl.pdf 8/15/2013
AP08/14/2013SLR36817022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021158Orig1s022ltr.pdf 8/16/2013
AP07/26/2016SLR46620023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021158s023lbl.pdf 7/26/2016
AP07/26/2016SLR46640023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021158Orig1s023ltr.pdf 7/26/2016




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