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FDA Drug Application 017581 by ATNAHS PHARMA US

Application Number017581
Application Type New Drug Application
Sponsor ApplicantATNAHS PHARMA US
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
AP03/11/1976N24022000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088657.pdf 11/19/2009
AP07/15/1980SES       
AP05/13/1976SLR       
AP011/29/1976SCM       
AP07/15/1980SCM16210004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/017581_S004_NAPROSYN_AP.pdf 4/11/2007
AP05/2/1979SCP       
AP05/2/1979SCP       
AP08/4/1978SCS       
AP011/27/1978SCS       
AP05/24/1979SCS       
AP05/2/1978SCM       
AP06/7/1979SCM       
AP02/15/1979SCS       
AP02/15/1979SCS       
AP07/17/1979SCS       
AP09/6/1979SCM       
AP07/9/1979SCP       
AP07/9/1979SCS       
AP04/14/1980SCF       
AP03/21/1980SCS       
AP05/13/1980SLR       
AP09/12/1980SLR       
AP04/15/1982SLR       
AP010/13/1981SLR       
AP04/13/1981SLR       
AP010/13/1981SCF       
AP04/2/1981SCS       
AP01/8/1982SCP       
AP010/13/1981SCS       
AP010/13/1981SCS       
AP010/13/1981SCS       
AP01/7/1982SCP       
AP012/21/1981SCP       
AP03/31/1982SCM       
AP03/31/1982SCM       
AP09/9/1983SLR       
AP01/13/1983SCS       
AP012/3/1982SLR       
AP012/3/1982SLR       
AP02/18/1988SCM       
AP04/23/1985SCS       
AP09/9/1983SLR       
AP04/29/1985SCM       
AP04/23/1985SCM       
AP012/16/1986SCF       
AP04/23/1985SCM       
AP03/23/1987SE2       
AP07/17/1986SCS       
AP06/10/1986SCP       
AP09/24/1985SLR       
AP012/16/1986SLR       
AP03/23/1987SE1       
AP04/21/1989SCF       
AP010/30/1991SCS       
AP04/21/1994SCP       
AP09/16/1991SCP       
AP05/8/1992SCP       
AP08/12/1992SCM       
AP09/12/1994SCS       
AP03/28/1994SCP       
AP012/8/1994SCM       
AP04/14/2003SLR5699098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17581slr098,18965slr007,18164slr049ltr.pdf 5/29/2003
AP011/10/2004SLR10585099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf 11/16/2004
AP011/10/2004SLR10601099   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf 11/16/2004
AP011/10/2004SLR10586100   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf 11/16/2004
AP011/10/2004SLR10602100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf 11/16/2004
AP012/8/2000SCM       
AP011/9/2001SCP       
AP02/22/2002SCM       
AP03/10/2006SLR13752105   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf 3/14/2006
AP03/10/2006SLR13808105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010,018965s013,018164s055, 017581s105ltr.pdf 3/23/2006
AP01/24/2006SLR13488106   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf 1/25/2006
AP01/24/2006SLR13525106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf 1/30/2006
AP04/19/2007SLR16321107   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf 4/25/2007
AP09/20/2007SLR17947108   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf 9/25/2007
AP09/20/2007SLR18020108   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf 9/26/2007
AP07/25/2008SLR20304110   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf 7/29/2008
AP07/25/2008SLR20319110   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf 7/30/2008
AP03/22/2013SLR35524111   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf 3/26/2013
AP03/22/2013SLR35547111   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf 3/26/2013
AP05/9/2016SLR45925112   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017581Orig1s112,018164Orig1s062,020067Orig1s019ltr.pdf 5/11/2016
AP05/9/2016SLR45976112   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf 5/11/2016




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