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FDA Drug Application 017377 by SUN PHARM INDS

Application Number017377
Application Type New Drug Application
Sponsor ApplicantSUN PHARM INDS
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
AP07/30/1973N       
AP06/12/1974S       
AP01/22/1975SCS       
AP012/5/1974SLR       
AP012/5/1974SLR       
AP04/14/1975SCS       
AP07/3/1975SCS       
AP02/12/1976SCS       
AP05/12/1976SCF       
AP02/15/1977SCS       
AP010/1/1976SCS       
AP011/22/1976SCS       
AP01/19/1977SLR       
AP05/2/1977SLR       
AP07/26/1979SLR       
AP01/12/1978SCS       
AP03/1/1978SLR       
AP04/18/1978SLR       
AP010/11/1978SLR       
AP04/19/1978SCS       
AP04/18/1979SCS       
AP012/17/1979SLR       
AP03/6/1980SCS       
AP02/23/1982SES       
AP010/31/1980SLR       
AP04/1/1981SCS       
AP04/23/1981SCS       
AP012/9/1981SLR       
AP010/9/1981SCS       
AP06/15/1983SCS       
AP06/15/1990SE1       
AP08/1/1983SCM       
AP05/9/1984SCP       
AP011/23/1984SLR       
AP06/12/1984SCS       
AP03/19/1985SCP       
AP08/11/1987SLR       
AP03/6/1996SLR       
AP05/11/1987SCS       
AP05/11/1987SCS       
AP07/3/2000SLR       
AP07/17/1990SCM       
AP07/3/2000SLR       
AP04/18/1994SCP       
AP011/17/1998SLR       
AP02/12/2003SLR3775057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17377slr057ltr.pdf 2/12/2003
AP02/12/2003SLR3780057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/17377slr057_Bactrim_lbl.pdf 2/12/2003
AP010/17/2002SCF3764058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17377scf058ltr.pdf 10/17/2002
AP010/17/2002SCF3765058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17377s58lbl.pdf 10/17/2002
AP06/5/2007SLR16715063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017377s063ltr.pdf 6/7/2007
AP06/5/2007SLR16719063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017377s063lbl.pdf 6/7/2007
AP06/28/2010SLR25907066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017377s066ltr.pdf 7/2/2010
AP07/27/2010SLR26035067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/017377s067ltr.pdf 7/29/2010
AP07/27/2010SLR26062067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/017377s067lbl.pdf 7/31/2010
AP07/12/2013SLR36555068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017377Orig1s068,s073ltr.pdf 7/15/2013
AP07/12/2013SLR36568068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf 7/17/2013
AP08/29/2012SLR33608071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017377Orig1s071ltr.pdf 8/31/2012
AP08/29/2012SLR33618071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017377s071lbl.pdf 8/31/2012
AP07/12/2013SLR36569073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017377s068s073lbl.pdf 7/17/2013
AP07/12/2013SLR36556073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017377Orig1s068,s073ltr.pdf 7/15/2013
AP07/16/2014SLR39882074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017377s074lbl.pdf 7/17/2014
AP07/16/2014SLR39886074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017377Orig1s074ltr.pdf 7/17/2014
AP04/7/2015SCM       
AP04/13/2015SCM       
AP011/27/2015SCM       
AP04/18/2016SCM       




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