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FDA Drug Application 012623 by GD SEARLE LLC

Application Number012623
Application Type New Drug Application
Sponsor ApplicantGD SEARLE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/18/1963N       
AP05/14/1974S       
AP05/14/1974SLR       
AP011/5/1975SLR       
AP010/5/1976SCS       
AP08/22/1977SLR       
AP04/19/1979SCF       
AP03/2/1979SLR       
AP07/26/1979SLR       
AP01/2/1980SCM       
AP02/27/1980SCF       
AP012/8/1980SLR       
AP01/9/1980SCF       
AP012/12/1980SCP       
AP08/4/1981SCM       
AP02/4/1982SCM       
AP08/13/1981SCP       
AP05/5/1982SCF       
AP010/18/1983SPF       
AP010/18/1983SLR       
AP06/2/1983SCS       
AP03/30/1984SLR       
AP08/21/1987SLR       
AP011/3/1987SLR       
AP02/10/1988SE5       
AP07/22/1986SLR       
AP012/28/1987SLR       
AP06/18/1987SCE       
AP02/3/1989SLR       
AP05/7/1996SLR       
AP05/7/1996SLR       
AP04/13/1989SLR       
AP05/7/1996SLR       
AP07/30/1990SCP       
AP05/7/1996SLR       
AP06/23/1992SCP       
AP02/16/1994SCP       
AP04/23/2003SLR5651058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/12623slr058_flagyl_lbl.pdf 5/28/2003
AP04/23/2003SLR5652058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12623slr058ltr.pdf 5/28/2003
AP03/17/2004SLR8025059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/12623slr059ltr.pdf 3/24/2004
AP03/17/2004SLR8210059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/12623slr059_flagyl_lbl.pdf 4/5/2004
AP08/19/2010SLR26276061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012623s061lbl.pdf 8/20/2010
AP08/19/2010SLR26280061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf 8/24/2010
AP08/16/2013SLR36842065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/012623Orig1s065ltr.pdf 8/20/2013
AP08/16/2013SLR36853065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012623s065lbl.pdf 8/21/2013
AP07/13/2015SLR43372066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012623Orig1s066ltr.pdf 7/15/2015
AP07/13/2015SLR43388066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012623s066lbl.pdf 7/16/2015




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