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FDA Drug Application 021187 by ORGANON USA INC

Application Number021187
Application Type New Drug Application
Sponsor ApplicantORGANON USA INC
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
AP010/3/2001N3054000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21187ltr.pdf 10/3/2001
AP010/3/2001N3055000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21187lbl.pdf 10/3/2001
AP010/3/2001N3056000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-187_NuvaRing.cfm 10/3/2001
AP03/27/2002SCS       
AP05/29/2002SCM       
AP02/5/2002SCM       
AP011/5/2002SCS       
AP02/4/2004SLR7759007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr007ltr.pdf 3/2/2004
AP03/2/2004SLR7848008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21187slr008ltr.pdf 3/10/2004
AP07/29/2005SE812504012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021187s012ltr.pdf 8/3/2005
AP07/29/2005SE812515012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021187s012lbl.pdf 8/3/2005
AP010/2/2007SLR18120017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021187s017ltr.pdf 10/4/2007
AP010/2/2007SLR18160017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021187s017lbl.pdf 10/4/2007
AP04/29/2008SLR19762018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021187s018ltr.pdf 5/5/2008
AP02/19/2016SCM       
AP010/4/2013SE837380021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s021lbl.pdf 10/8/2013
AP010/4/2013SE837471021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s021ltr.pdf 10/21/2013
AP010/4/2013SE841575021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf 1/9/2015
AP010/4/2013SE842081021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm 3/10/2015
AP010/4/2013SLR37381022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021187s022lbl.pdf 10/8/2013
AP010/4/2013SLR37472022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021187Orig1s022ltr.pdf 10/21/2013
AP010/4/2013SLR41576022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022SumR.pdf 1/9/2015
AP010/4/2013SLR42432022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021187Orig1s021s022TOC.cfm 4/6/2015
AP07/19/2013SCM       
AP06/18/2014SLR39592024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s024ltr.pdf 6/19/2014
AP06/18/2014SLR39623024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s024lbl.pdf 6/23/2014
AP010/31/2014SLR40916025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021187Orig1s025ltr.pdf 11/3/2014
AP010/31/2014SLR40965025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021187s025lbl.pdf 11/7/2014
AP09/30/2016SE847274027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021187Orig1s027ltr.pdf 10/4/2016
AP09/30/2016SE847303027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021187s027lbl.pdf 10/6/2016




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