Back to FDA Applications sponsored by ATNAHS PHARMA US

FDA Drug Application 018164 by ATNAHS PHARMA US

Application Number018164
Application Type New Drug Application
Sponsor ApplicantATNAHS PHARMA US
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/4/1980N23883000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085911.pdf 11/16/2009
AP09/4/1980N12321000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm 7/28/2005
AP04/13/1981SLR       
AP010/13/1981SCS       
AP010/13/1981SCS       
AP01/7/1982SCP       
AP01/7/1982SCP       
AP05/10/1982SCP       
AP04/22/1982SCM       
AP04/22/1982SCM       
AP04/22/1982SCM       
AP09/9/1983SLR       
AP010/18/1982SCS       
AP04/23/1985SCF       
AP09/30/1987SLR       
AP012/7/1982SLR       
AP012/7/1982SLR       
AP02/22/1983SCS       
AP08/29/1986SCS       
AP09/9/1983SLR       
AP04/29/1985SCM       
AP09/30/1987SCF       
AP05/3/1985SCM       
AP09/24/1985SLR       
AP06/10/1986SCP       
AP09/30/1987SLR       
AP09/30/1987SE2       
AP09/30/1987SE1       
AP010/2/1990SCS       
AP05/8/1992SCP       
AP08/12/1992SCM       
AP012/15/1993SLR       
AP02/8/1995SCF       
AP09/6/1994SCM       
AP04/14/2003SLR5701049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17581slr098,18965slr007,18164slr049ltr.pdf 5/29/2003
AP011/10/2004SLR10587050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf 11/16/2004
AP011/10/2004SLR10603050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf 11/16/2004
AP011/10/2004SLR10604051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6lbl.pdf 11/16/2004
AP011/10/2004SLR10588051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17581s99,100,18164s50,51,18965s9,10,20067s4,6ltr.pdf 11/16/2004
AP012/8/2000SCM       
AP011/9/2001SCP       
AP02/22/2002SCM       
AP03/10/2006SLR13753055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020067s010,018965s013,018164s055, 017581s105lbl.pdf 3/14/2006
AP03/10/2006SLR13809055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020067s010,018965s013,018164s055, 017581s105ltr.pdf 3/23/2006
AP01/24/2006SLR13487056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017581s106,018164s056,018965s014,020067s011lbl.pdf 1/25/2006
AP01/24/2006SLR13524056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017581s106_020067s011_018164s056ltr.pdf 1/30/2006
AP04/19/2007SLR16320057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s107, 018164s057, 018965s015, 020067s013_ltr.pdf 4/25/2007
AP09/20/2007SLR17948058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017581s108,18164s58,18965s16,20067s14ltr.pdf 9/25/2007
AP09/20/2007SLR18019058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017581s108,18164s58,18965s16,20067s14lbl.pdf 9/26/2007
AP07/25/2008SLR20305060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017581s110,18164s60,18965s18,20067s17lbl.pdf 7/29/2008
AP07/25/2008SLR20320060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017581s110,018164s060,018965s018,020067s017ltr.pdf 7/30/2008
AP03/22/2013SLR35523061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017581s111,018164s061,018965s020,020067s018lbl.pdf 3/26/2013
AP03/22/2013SLR35548061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017581Orig1s111,018164Orig1s061,018965Orig1s020,020067Orig1s018ltr.pdf 3/26/2013
AP05/9/2016SLR45926062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017581Orig1s112,018164Orig1s062,020067Orig1s019ltr.pdf 5/11/2016
AP05/9/2016SLR45977062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017581s112,018164s062,020067s019lbl.pdf 5/11/2016




Back to FDA Applications sponsored by ATNAHS PHARMA US

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.