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FDA Drug Application 021225 by BAYER HLTHCARE

Application Number021225
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/6/2000N8527000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-225_Mirena.cfm 5/6/2004
AP010/29/2001SCP       
AP010/12/2001SLR       
AP012/5/2001SCM       
AP03/29/2002SCS       
AP03/4/2002SCS       
AP011/27/2002SCS       
AP01/8/2004SLR7527009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21225slr009ltr.pdf 1/14/2004
AP08/27/2003SCE6584010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21225sce010ltr.pdf 8/29/2003
AP05/28/2008SLR19908017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s017ltr.pdf 5/30/2008
AP06/2/2008SLR19960018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s018ltr.pdf 6/6/2008
AP07/21/2008SLR20269019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf 7/22/2008
AP07/21/2008SLR20288019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021225s019ltr.pdf 7/24/2008
AP010/1/2009SE123564027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021225s027lbl.pdf 10/14/2009
AP010/1/2009SE123790027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021225s027ltr.pdf 11/10/2009
AP03/7/2014SCM       
AP010/22/2015SLR44291031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021225s031lbl.pdf 10/26/2015
AP010/22/2015SLR44300031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021225Orig1s031ltr.pdf 10/26/2015
AP010/22/2015SLR45095031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021225Orig1s031.pdf 2/3/2016
AP08/7/2013SLR36728032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021225Orig1s032_correctionltr.pdf 8/8/2013
AP08/7/2013SLR36765032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021225s032lbl.pdf 8/9/2013
AP05/29/2014SCM39401033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021225s033lbl.pdf 5/30/2014
AP05/29/2014SCM42047033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021225Orig1s033.pdf 3/9/2015
AP05/8/2014SCM       
AP012/8/2014SCM       




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