Back to FDA Applications sponsored by MALLINCKRODT

FDA Drug Application 017116 by MALLINCKRODT

Application Number017116
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT
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
AP03/14/1973N15399000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142827.htm 11/27/2006
AP08/6/1976SCF       
AP02/11/1977SLR       
AP02/6/1980SLR       
AP02/6/1980SCM       
AP011/25/1981SCF       
AP09/7/1982SCF       
AP04/20/1993SLR       
AP04/3/2000SCS       
AP03/27/2002SCS3562014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17116s014ltr.pdf 3/27/2002
AP05/26/2005SLR11725015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s015,016ltr.pdf 5/27/2005
AP05/26/2005SLR11744015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf 5/27/2005
AP05/26/2005SLR11726016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s015,016ltr.pdf 5/27/2005
AP05/26/2005SLR11745016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017116s015,016lbl.pdf 5/27/2005
AP08/3/2005SCS12544018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s018,019ltr.pdf 8/8/2005
AP08/3/2005SCS12545019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017116s018,019ltr.pdf 8/8/2005
AP02/4/2008SLR19072021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017116s021ltr.pdf 2/7/2008
AP02/4/2008SLR19130021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017116s021lbl.pdf 2/14/2008
AP06/2/2014SCM       
AP09/22/2014SCM       




Back to FDA Applications sponsored by MALLINCKRODT