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FDA Drug Application 019038 by GD SEARLE LLC

Application Number019038
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
AP03/30/1984N       
AP07/10/1984SCM       
AP04/13/2010SLR25273003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018925s007,019038s003ltr.pdf 4/19/2010
AP04/13/2010SLR25301003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018925s007,019038s003lbl.pdf 4/19/2010
AP011/2/2011SLR30496004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019038s004lbl.pdf 11/4/2011
AP011/2/2011SLR30525004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019038s004ltr.pdf 11/7/2011
AP08/24/2016SLR46885005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019038Orig1s005ltr.pdf 8/25/2016




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