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FDA Drug Application 022201 by FERRING

Application Number022201
Application Type New Drug Application
Sponsor ApplicantFERRING
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/24/2008N21412000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022201lbl.pdf 12/29/2008
AP012/24/2008N21430000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022201s000ltr.pdf 12/30/2008
AP012/24/2008N21845000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022201s000_TOC.cfm 2/17/2009
AP012/24/2008N21846000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022201s000_SumR.pdf 2/17/2009
AP03/5/2013SLR35349002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022201Orig1s002ltr.pdf 3/6/2013
AP03/5/2013SLR35389002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s002lbl.pdf 3/8/2013
AP08/16/2013SLR36840003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022201Orig1s003ltr.pdf 8/20/2013
AP08/16/2013SLR36851003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022201s003lbl.pdf 8/21/2013
AP03/25/2014SCM       
AP09/26/2014SCM       
AP011/10/2014SCM       
AP012/15/2014SCM       
AP02/26/2015SLR41950009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022201Orig1s009ltr.pdf 2/27/2015
AP02/26/2015SLR41990009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s009lbl.pdf 3/3/2015
AP07/31/2015SCM       
AP010/27/2015SLR44324011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022201Orig1s011ltr.pdf 10/28/2015
AP010/27/2015SLR44379011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022201s011lbl.pdf 11/4/2015
AP01/12/2016SCM       
AP06/21/2016SCM       




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