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FDA Drug Application 087845 by MALLINCKRODT INC

Application Number087845
Application Type Abbreviated New Drug Application
Sponsor ApplicantMALLINCKRODT INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/22/1984N16543000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP08/7/1986SC       
AP08/7/1986SC       
AP010/23/1986SC       
AP012/14/1992SC       
AP02/2/1993SLI       
AP012/14/1992SC       
AP02/25/1993SC       
AP012/20/1994SL       
AP09/1/1998SL       
AP09/26/1997SC       
AP07/15/1999SC       
AP09/14/2000SCB       
AP09/14/2000SCB       
AP06/12/2002SCB       
AP09/27/2007SLR35423025Prescribing Information  http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/087844s025,087845s025,087846s025pi.pdf 3/12/2013
AP09/27/2007SLR35427025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/087844s025,087845s025,087846s026medg.pdf 3/12/2013
AP09/27/2007SLR35445025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/087844Orig1s025,087845Orig1s025,087846Orig1s026ltr.pdf 3/13/2013
AP09/17/2014SLR40435027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087846s028,087844s027,087845s027lbl.pdf 9/5/2014




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