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FDA Drug Application 020552 by GD SEARLE LLC

Application Number020552
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
AP02/26/1996N       
AP01/13/1998SLR       
AP01/31/2003SLR8878002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20552slr002ltr.pdf 6/2/2004
AP06/29/2009SLR22860005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020552s005lbl.pdf 6/30/2009
AP06/29/2009SLR22887005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020552s005ltr.pdf 7/7/2009
AP04/13/2010SLR25327006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020552s006ltr.pdf 4/21/2010
AP04/13/2010SLR25401006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020552s006lbl.pdf 4/30/2010
AP011/2/2011SLR30494007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020552s007lbl.pdf 11/4/2011
AP011/2/2011SLR30526007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020552s007ltr.pdf 11/7/2011
AP08/24/2016SLR46882009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020552Orig1s009ltr.pdf 8/25/2016




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