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FDA Drug Application 018012 by MALLINCKRODT INC

Application Number018012
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/1/1977N16530000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP08/1/1977N24045000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088671.pdf 11/20/2009
AP06/29/1978SES       
AP02/18/1982SCM       
AP06/15/1979SCP       
AP01/31/1980SCF       
AP03/25/1981SCP       
AP07/7/1982SCM       
AP05/1/1984SLR       
AP06/11/1985SLR       
AP08/25/1986SCS       
AP04/13/1989SCS       
AP03/26/1990SCM       
AP03/29/1994SCS       
AP012/23/1999SCS       
AP07/31/2001SLR23308024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/018012_s024_PAMELOR CAPSULES.pdf 9/14/2009
AP07/31/2001SLR5221024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/018012s24lbl.pdf 4/11/2003
AP01/12/2005SLR10977026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18012s026,18013s056ltr.pdf 1/13/2005
AP01/12/2005SLR10997026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf 1/13/2005
AP07/13/2007SLR17287027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018012s27lbl.pdf 7/16/2007
AP07/13/2007SLR17348027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf 7/24/2007
AP010/26/2012SLR34182029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf 10/26/2012
AP010/26/2012SLR34197029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf 10/29/2012
AP07/10/2014SLR39841030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s030lbl.pdf 7/11/2014
AP07/10/2014SLR39853030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf 7/11/2014
AP07/28/2014SLR40030031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf 7/29/2014
AP07/28/2014SLR40036031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018012s031lbl.pdf 7/29/2014




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