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FDA Drug Application 017090 by MALLINCKRODT INC

Application Number017090
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/11/1973N16541000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP03/11/1973N34201000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM326090.pdf 10/29/2012
AP05/22/1974SOA       
AP05/22/1974SOA       
AP05/22/1974SOA       
AP05/22/1974SOA       
AP05/22/1974SOA       
AP05/28/1974SCS       
AP05/28/1974SCS       
AP05/28/1974SCS       
AP05/28/1974SCS       
AP05/28/1974SCS       
AP05/28/1974SCS       
AP06/3/1974SCS       
AP012/3/1975SCS       
AP06/7/1977SCS       
AP01/2/1979SLR       
AP012/28/1979SCS       
AP012/28/1979SCS       
AP06/7/1979SCM       
AP06/7/1979SCP       
AP01/30/1980SCP       
AP04/16/1980SCP       
AP04/16/1980SCM       
AP02/4/1981SLR       
AP07/18/1986SCE       
AP05/4/1983SCP       
AP011/5/1984SCS       
AP03/26/1984SLR       
AP010/29/1984SCS       
AP04/26/1985SLR       
AP05/5/1985SCS       
AP011/27/1985SLR       
AP05/20/1986SCS       
AP08/12/1987SE2       
AP04/7/1989SCP       
AP08/8/1989SCM       
AP010/25/1989SCM       
AP010/25/1989SCM       
AP04/5/1990SCP       
AP08/2/1991SCS       
AP012/8/1992SLR       
AP02/19/1993SCS       
AP03/27/2000SLR       
AP03/27/2000SLR       
AP03/27/2000SLR       
AP07/31/1997SCS       
AP04/15/1999SCP       
AP04/26/2000SCS       
AP06/21/2000SCM       
AP01/3/2002SLR       
AP06/20/2002SCM       
AP03/26/2004SLR8124069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17090slr069ltr.pdf 3/28/2004
AP01/12/2005SLR10966070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/17090s070ltr.pdf 1/13/2005
AP01/12/2005SLR10986070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/17090s070lbl.pdf 1/13/2005
AP07/13/2007SLR17284074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017090s74lbl.pdf 7/16/2007
AP07/13/2007SLR17349074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017090s74,18012s27,18013s58,19906s34ltr.pdf 7/24/2007
AP010/26/2012SLR34181076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017090s076lbl.pdf 10/26/2012
AP010/26/2012SLR34199076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019906Orig1s037,018012Orig1029,018013Orig1s061,017090Orig1s076ltr.pdf 10/29/2012
AP07/10/2014SLR39840077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s077lbl.pdf 7/11/2014
AP07/10/2014SLR39855077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s030,018013Orig1s062,017090Orig1s077,019906Orig1s038ltr.pdf 7/11/2014
AP07/28/2014SLR40032078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018012Orig1s031,018013Orig1s063,017090Orig1s078,019906Orig1s039ltr.pdf 7/29/2014
AP07/28/2014SLR40038078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017090s078lbl.pdf 7/29/2014




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