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FDA Drug Application 019906 by MALLINCKRODT LLC

Application Number019906
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/1989N16484000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP012/29/1989N23882000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085910.pdf 11/16/2009
AP04/9/1991SLR       
AP01/31/1991SCF       
AP04/9/1991SLR       
AP05/15/1991SCS       
AP04/9/1991SLR       
AP04/13/1994SLR       
AP07/31/2001SLR5907009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19906s9lbl.pdf 6/10/2003
AP07/1/1994SCS       
AP07/13/1994SCS       
AP04/13/1994SLR       
AP010/5/1995SCS       
AP010/20/1995SCM       
AP012/14/1995SCS       
AP011/22/1995SCM       
AP04/2/1997SLR       
AP02/11/1997SCS       
AP04/2/1997SLR       
AP01/15/1998SLR       
AP05/18/1998SCS       
AP01/4/1999SLR16759022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019906_S022_ANAFRANIL_AP.pdf 6/12/2007
AP03/8/1999SCM       
AP04/15/1999SCP       
AP07/3/2000SCM       
AP010/31/2000SCM       
AP03/23/2001SCS       
AP06/20/2002SCM       
AP09/3/2004SLR10139030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19906s030ltr.pdf 9/7/2004
AP01/12/2005SLR10959032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019906s032ltr.pdf 1/13/2005
AP01/12/2005SLR10983032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019906s032lbl.pdf 1/13/2005
AP07/13/2007SLR17285034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019906s34lbl.pdf 7/16/2007
AP07/13/2007SLR17346034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf 7/24/2007
AP010/26/2012SLR34184037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019906s037lbl.pdf 10/26/2012
AP010/26/2012SLR34196037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf 10/29/2012
AP07/10/2014SLR39839038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s038lbl.pdf 7/11/2014
AP07/10/2014SLR39856038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf 7/11/2014
AP07/28/2014SLR40033039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf 7/29/2014
AP07/28/2014SLR40039039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019906s039lbl.pdf 7/29/2014




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