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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 10/3/2001
AP010/3/2001N3055000 10/3/2001
AP010/3/2001N3056000 10/3/2001
AP02/4/2004SLR7759007 3/2/2004
AP03/2/2004SLR7848008 3/10/2004
AP07/29/2005SE812504012 8/3/2005
AP07/29/2005SE812515012 8/3/2005
AP010/2/2007SLR18120017 10/4/2007
AP010/2/2007SLR18160017 10/4/2007
AP04/29/2008SLR19762018 5/5/2008
AP010/4/2013SE841575021 1/9/2015
AP010/4/2013SE837380021 10/8/2013
AP010/4/2013SE837471021 10/21/2013
AP010/4/2013SE842081021 3/10/2015
AP010/4/2013SLR42432022 4/6/2015
AP010/4/2013SLR37472022 10/21/2013
AP010/4/2013SLR37381022 10/8/2013
AP010/4/2013SLR41576022 1/9/2015
AP06/18/2014SLR39592024 6/19/2014
AP06/18/2014SLR39623024 6/23/2014
AP010/31/2014SLR40916025 11/3/2014
AP010/31/2014SLR40965025 11/7/2014
AP09/30/2016SE847274027 10/4/2016
AP09/30/2016SE847303027 10/6/2016

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