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FDA Drug Application 020067 by ATNAHS PHARMA US

Application Number020067
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/14/1994N23951000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088585.pdf 11/18/2009
AP012/6/1994SCM       
AP06/28/1996SCM       
AP07/9/1997SCM       
AP011/10/2004SLR10591004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf 11/16/2004
AP011/10/2004SLR10607004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf 11/16/2004
AP05/19/2003SLR5806005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20067slr005ltr.pdf 6/8/2003
AP011/10/2004SLR10592006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf 11/16/2004
AP011/10/2004SLR10608006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf 11/16/2004
AP011/9/2001SCP       
AP02/22/2002SCM       
AP03/10/2006SLR13755010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf 3/14/2006
AP03/10/2006SLR13811010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010ltr.pdf 3/23/2006
AP01/24/2006SLR13485011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf 1/25/2006
AP01/24/2006SLR13523011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf 1/30/2006
AP04/19/2007SLR16318013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf 4/25/2007
AP09/20/2007SLR17950014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf 9/25/2007
AP09/20/2007SLR18017014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf 9/26/2007
AP07/25/2008SLR20307017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf 7/29/2008
AP07/25/2008SLR20322017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf 7/30/2008
AP03/22/2013SLR35521018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf 3/26/2013
AP03/22/2013SLR35550018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf 3/26/2013
AP05/9/2016SLR45927019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017581Orig1s112,018164Orig1s062,020067Orig1s019ltr.pdf 5/11/2016
AP05/9/2016SLR45978019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf 5/11/2016




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