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FDA Drug Application 020415 by ORGANON USA INC

Application Number020415
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
AP06/14/1996N12416000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm 8/1/2005
AP06/14/1996N24065000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089021.pdf 11/20/2009
AP011/4/1996SCS       
AP011/7/1996SCS       
AP03/17/1997SCS10150003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-415s003_Remeron.cfm 9/8/2004
AP04/9/1998SCM       
AP05/11/1999SCM       
AP08/30/2000SLR       
AP02/28/2000SLR       
AP07/19/2000SCS       
AP04/9/2002SE83131009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20415s9ltr.pdf 4/16/2002
AP01/26/2001SCM       
AP011/20/2001SCM       
AP09/30/2002SLR3130015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20415slr015ltr.pdf 10/2/2002
AP06/1/2004SLR9098016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20415slr016,21208slr008ltr.pdf 6/7/2004
AP01/12/2005SLR10956018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020415s018,021208s009ltr.pdf 1/13/2005
AP01/12/2005SLR10980018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf 1/13/2005
AP07/30/2007SLR17435019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020415s019,021208s010lbl.pdf 7/31/2007
AP07/30/2007SLR17471019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020415s019, 021208s010ltr.pdf 8/2/2007
AP012/27/2011SLR31288022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020415s022lbl.pdf 12/27/2011
AP012/27/2011SLR31299022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020415s022ltr.pdf 12/29/2011
AP05/14/2010SLR25596023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf 5/21/2010
AP05/14/2010SLR25638023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf 5/28/2010
AP05/14/2010SLR25639024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020415s023s024.pdf 5/28/2010
AP05/14/2010SLR25597024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf 5/21/2010
AP010/30/2012SLR34212026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020415Orig1s026,021208Orig1s016ltr.pdf 11/1/2012
AP010/30/2012SLR34320026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026lbl.pdf 11/6/2012
AP010/30/2012SLR34323026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020415s026mg.pdf 11/6/2012
AP012/11/2012SCM       
AP09/30/2014SCM       
AP07/8/2016SLR46692030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020415s030lbl.pdf 8/1/2016
AP07/8/2016SLR46715030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020415Orig1s030,021208Orig1s020ltr.pdf 8/3/2016
AP07/18/2014SLR39935031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020415Orig1s031,021208Orig1s021ltr.pdf 7/23/2014
AP07/18/2014SLR40060031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf 7/30/2014
AP012/30/2015SLR44921032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020415Orig1s032,021208Orig1s022ltr.pdf 12/31/2015
AP012/30/2015SLR44927032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020415s032lbl.pdf 12/31/2015




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