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FDA Drug Application 021258 by BAYER HLTHCARE

Application Number021258
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/21/2003N7000000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21258ltr.pdf 11/28/2003
AP011/21/2003N8183000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021258lbl.pdf 4/1/2004
AP011/21/2003N14249000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021258s000_ClimaraTOC.cfm 6/7/2006
AP06/22/2005SLR11888003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021258s003ltr.pdf 6/24/2005
AP06/22/2005SLR11891003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021258s003lbl.pdf 6/24/2005
AP010/9/2013SLR37406006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021258Orig1s006ltr.pdf 10/11/2013
AP010/9/2013SLR37443006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021258s006lbl.pdf 10/17/2013
AP03/8/2016SCM       




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