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FDA Drug Application 021208 by ORGANON USA INC

Application Number021208
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
AP01/12/2001N3144000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-208_Remeron_Approv.pdf 1/12/2001
AP01/12/2001N3145000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-208_Remeron_prntlbl.pdf 1/12/2001
AP01/12/2001N3146000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021208_remeron.cfm 4/29/2002
AP01/12/2001N12417000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109344.htm 8/1/2005
AP01/12/2001N31638000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM289881.pdf 2/3/2012
AP02/22/2001SLR       
AP03/23/2001SCM       
AP011/20/2001SCM       
AP04/3/2002SCS       
AP05/21/2002SCM       
AP011/14/2002SLR6137006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21205slr006ltr.pdf 7/24/2003
AP06/1/2004SLR9099008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20415slr016,21208slr008ltr.pdf 6/7/2004
AP01/12/2005SLR10957009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020415s018,021208s009ltr.pdf 1/13/2005
AP01/12/2005SLR10981009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020415s018,021208s009lbl.pdf 1/13/2005
AP07/30/2007SLR17434010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020415s019,021208s010lbl.pdf 7/31/2007
AP07/30/2007SLR17470010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020415s019, 021208s010ltr.pdf 8/2/2007
AP012/23/2011SLR31334012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021208s012ltr.pdf 1/3/2012
AP012/23/2011SLR31528012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021208s012.pdf 1/26/2012
AP05/14/2010SLR25598013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf 5/21/2010
AP05/14/2010SLR25637013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021208s013s014lbl.pdf 5/28/2010
AP05/14/2010SLR25599014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020415s023,s024,021208s013,s014ltr.pdf 5/21/2010
AP05/14/2010SLR25636014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021208s013s014lbl.pdf 5/28/2010
AP010/30/2012SLR34213016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020415Orig1s026,021208Orig1s016ltr.pdf 11/1/2012
AP010/30/2012SLR34321016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021208s016lbl.pdf 11/6/2012
AP010/30/2012SLR34322016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021208s016mg.pdf 11/6/2012
AP09/30/2014SCM       
AP07/8/2016SLR46691020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021208s020lbl.pdf 8/1/2016
AP07/8/2016SLR46716020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020415Orig1s030,021208Orig1s020ltr.pdf 8/3/2016
AP07/18/2014SLR39936021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020415Orig1s031,021208Orig1s021ltr.pdf 7/23/2014
AP07/18/2014SLR40059021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020415Orig1s031, 021208Orig1s021lbl.pdf 7/30/2014
AP012/30/2015SLR44922022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020415Orig1s032,021208Orig1s022ltr.pdf 12/31/2015
AP012/30/2015SLR44926022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021208s022lbl.pdf 12/31/2015




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