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FDA Drug Application 020845 by MALLINCKRODT HOSP

Application Number020845
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT HOSP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1999N385000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20845ltr.pdf 12/23/1999
AP012/23/1999N386000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20845lbl.htm 12/23/1999
AP012/23/1999N1900000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20845_INOmax.cfm 12/23/1999
AP05/21/2001SLR       
AP06/15/2004SLR9401002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20845slr002ltr.pdf 6/16/2004
AP012/4/2007SLR18863004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020845s004ltr.pdf 1/9/2008
AP08/26/2009SLR23388009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020845s009lbl.pdf 9/17/2009
AP08/26/2009SLR23989009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020845s009ltr.pdf 11/19/2009
AP012/21/2010SE827338011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020845s011ltr.pdf 12/22/2010
AP012/21/2010SE827341011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020845s011lbl.pdf 12/22/2010
AP03/4/2013SLR35335014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020845Orig1s014ltr.pdf 3/5/2013
AP03/4/2013SLR35393014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020845s014lbl.pdf 3/8/2013
AP03/4/2013SLR46647014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020845Orig1s014.pdf 7/27/2016
AP02/28/2014SCM       
AP010/9/2015SLR44198016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020845Orig1s016,s017ltr.pdf 10/14/2015
AP010/9/2015SLR44211016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf 10/15/2015
AP010/9/2015SE844199017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020845Orig1s016,s017ltr.pdf 10/14/2015
AP010/9/2015SE844212017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdf 10/15/2015
AP010/9/2015SE846648017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020845Orig1s017.pdf 7/27/2016
AP04/5/2016SLR45599018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020845Orig1s018ltr.pdf 4/7/2016




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