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FDA Drug Application 021529 by ORGANON USA INC

Application Number021529
Application Type New Drug Application
Sponsor ApplicantORGANON USA INC
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
AP07/17/2006N14481000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021529lbl.pdf 7/21/2006
AP07/17/2006N14501000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021529s000_ltr.pdf 7/21/2006
AP07/17/2006N23976000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021529_implanon_toc.cfm 11/19/2009
AP01/18/2007SLR15703001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021529s001ltr.pdf 1/25/2007
AP02/19/2009SLR21889004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021529s004lbl.pdf 2/20/2009
AP02/19/2009SLR21897004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021529s004ltr.pdf 2/23/2009
AP02/1/2012SLR31653006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021529s006ltr.pdf 2/3/2012
AP02/1/2012SLR31689006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021529s006lbl.pdf 2/6/2012
AP05/13/2011SE828837007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021529s007lbl.pdf 5/16/2011
AP05/13/2011SE828862007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021529s007ltr.pdf 5/19/2011
AP05/28/2014SLR39821008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021529s008lblrev.pdf 7/9/2014
AP17/3/2014SLR39821008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021529s008lblrev.pdf 7/9/2014
AP06/12/2013SCM       
AP09/27/2013SLR37282010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021529Orig1s010ltr.pdf 10/1/2013
AP09/27/2013SLR37300010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021529s010lbl.pdf 10/1/2013
AP08/19/2015SLR43681011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021529s011lbl.pdf 8/20/2015
AP08/19/2015SLR43684011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021529Orig1s011ltr.pdf 8/21/2015
AP09/3/2015SCM       
AP03/14/2016SLR45446013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021529s013lbl.pdf 3/15/2016
AP03/14/2016SLR45449013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021529Orig1s013ltr.pdf 3/16/2016




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