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FDA Drug Application 020334 by GD SEARLE LLC

Application Number020334
Application Type New Drug Application
Sponsor ApplicantGD SEARLE LLC
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
AP05/3/1995N       
AP04/23/2003SLR5505001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020334s001lbl.pdf 4/28/2003
AP04/23/2003SLR5724001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20334slr001ltr.pdf 5/29/2003
AP03/17/2004SLR8016003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20334slr003ltr.pdf 3/24/2004
AP03/17/2004SLR8262003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20334slr003_flagyl_lbl.pdf 4/5/2004
AP08/19/2010SLR26275004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020334s004lbl.pdf 8/20/2010
AP08/19/2010SLR26281004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012623s061,020334s004,020868s008ltr.pdf 8/24/2010
AP08/16/2013SLR36846008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020334Orig1s008ltr.pdf 8/20/2013
AP08/16/2013SLR36855008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020334s008lbl.pdf 8/21/2013
AP07/13/2015SLR43368009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020334Orig1s009ltr.pdf 7/14/2015
AP07/13/2015SLR43386009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020334s009lbl.pdf 7/16/2015




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