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FDA Drug Application 018714 by BAYER HLTHCARE

Application Number018714
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
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
AP012/29/1982N       
AP05/11/1983SLR       
AP08/20/1985SLR       
AP011/9/1988SLR       
AP08/9/1988SCS       
AP08/9/1988SCS       
AP011/7/1989SCS       
AP07/14/2004SLR9797008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf 7/21/2004
AP07/14/2004SLR9799008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf 7/21/2004
AP07/14/2004S9796009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf 7/21/2004
AP07/14/2004S9800009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf 7/21/2004
AP08/16/2010SLR26230012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018714s012lbl.pdf 8/1/2010
AP08/16/2010SLR26267012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018714s012ltr.pdf 8/20/2010
AP02/25/2014SLR38608013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018714Orig1s013ltr.pdf 2/27/2014
AP02/25/2014SLR38673013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018714s013lbl.pdf 3/5/2014
AP09/18/2014SCM       
AP011/20/2014SCM       




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