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FDA Drug Application 020868 by GD SEARLE LLC

Application Number020868
Application Type New Drug Application
Sponsor ApplicantGD SEARLE LLC
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
AP011/26/1997N4281000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020868a.pdf 11/26/1997
AP02/20/1998SCP       
AP07/24/1998SCM       
AP010/8/1998SLR       
AP011/4/1998SCP       
AP04/23/2003SLR5506005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020868s005lbl.pdf 4/28/2003
AP04/23/2003SLR5725005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20868slr005ltr.pdf 5/29/2003
AP03/17/2004SLR8008006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20868slr006ltr.pdf 3/24/2004
AP03/17/2004SLR8244006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20868slr006_flagyl_lbl.pdf 4/5/2004
AP08/19/2010SLR26274008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020868s008lbl.pdf 8/20/2010
AP08/19/2010SLR26282008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf 8/24/2010
AP08/16/2013SLR36845009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020868Orig1s009ltr.pdf 8/20/2013
AP08/16/2013SLR36854009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020868s009lbl.pdf 8/21/2013
AP04/14/2015SCM       
AP07/13/2015SLR43369011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020868Orig1s011ltr.pdf 7/14/2015
AP07/13/2015SLR43385011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020868s011lbl.pdf 7/16/2015




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