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FDA Drug Application 018965 by ATNAHS PHARMA US

Application Number018965
Application Type New Drug Application
Sponsor ApplicantATNAHS PHARMA US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/23/1987N24023000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088657.pdf 11/19/2009
AP01/27/1993SCM       
AP09/12/1994SCS       
AP04/14/2003SLR5700007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17581slr098,18965slr007,18164slr049ltr.pdf 5/29/2003
AP011/14/1996SCM       
AP011/10/2004SLR10589009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf 11/16/2004
AP011/10/2004SLR10605009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf 11/16/2004
AP011/10/2004SLR10590010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf 11/16/2004
AP011/10/2004SLR10606010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf 11/16/2004
AP01/5/2001SCM       
AP02/22/2002SCM       
AP03/10/2006SLR13754013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf 3/14/2006
AP03/10/2006SLR13810013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010,018965s013,018164s055, 017581s105ltr.pdf 3/23/2006
AP01/24/2006SLR13486014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf 1/25/2006
AP01/24/2006SLR13526014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf 1/30/2006
AP04/19/2007SLR16319015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf 4/25/2007
AP09/20/2007SLR17949016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf 9/25/2007
AP09/20/2007SLR18018016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf 9/26/2007
AP07/25/2008SLR20306018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf 7/29/2008
AP07/25/2008SLR20321018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf 7/30/2008
AP03/22/2013SLR35522020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf 3/26/2013
AP03/22/2013SLR35549020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf 3/26/2013
AP07/30/2015SCM       
AP05/9/2016SLR45980022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018965s022s023lbl.pdf 5/11/2016
AP05/9/2016SLR46008022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018965Orig1s022.s023ltr.pdf 5/12/2016
AP05/9/2016SLR45979023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018965s022s023lbl.pdf 5/11/2016
AP05/9/2016SLR46009023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018965Orig1s022.s023ltr.pdf 5/12/2016
AP05/9/2016SCM       




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