Back to FDA Applications sponsored by MALLINCKRODT INC

FDA Drug Application 021217 by MALLINCKRODT INC

Application Number021217
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/1/2010N24882000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM204267.pdf 3/2/2010
AP03/1/2010N24883000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021217lbl.pdf 3/2/2010
AP03/1/2010N24917000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021217s000ltr.pdf 3/3/2010
AP03/1/2010N25605000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021217s000TOC.cfm 5/23/2010
AP03/1/2010N25606000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021217s000SumR.pdf 5/23/2010
AP03/1/2010N33132000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 7/11/2012
AP03/24/2010S25146001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021217s001ltr.pdf 3/31/2010
AP07/9/2012SLR33143002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021217Orig1s002ltr.pdf 7/11/2012
AP07/9/2012SLR33165002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s002lbl.pdf 7/12/2012
AP08/24/2012SLR33562004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021217Orig1s004ltr.pdf 8/28/2012
AP08/24/2012SLR33574004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s004mg.pdf 8/28/2012
AP08/24/2012SLR33578004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021217s004lbl.pdf 8/28/2012
AP03/18/2013SLR35476005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021217s005lbl.pdf 3/18/2013
AP03/18/2013SLR35477005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021217Orig1s005ltr.pdf 3/19/2013
AP04/15/2013SLR35736006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021217Orig1s006ltr.pdf 4/17/2013
AP06/2/2015SLR42979009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021217Orig1s009ltr.pdf 6/4/2015
AP06/2/2015SLR42986009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021217s009lbl.pdf 6/4/2015
AP06/17/2014SLR39584012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021217Orig1s012ltr.pdf 6/19/2014
AP06/17/2014SLR39665012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217Orig1s012lbl.pdf 6/26/2014
AP04/16/2014SLR39065013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021217s013lbl.pdf 4/16/2014
AP04/16/2014SLR39076013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021217Orig1s013ltr.pdf 4/17/2014
AP08/19/2014S40271014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021217Orig1s014ltr.pdf 8/20/2014
AP06/26/2015S43226015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021217Orig1s015ltr.pdf 7/2/2015
AP04/20/2016S45718017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021217Orig1s017ltr.pdf 4/22/2016
AP09/30/2016S47267020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021217Orig1s020ltr.pdf 10/4/2016




Back to FDA Applications sponsored by MALLINCKRODT INC