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FDA Drug Application 018163 by MALLINCKRODT INC

Application Number018163
Application Type New Drug Application
Sponsor ApplicantMALLINCKRODT INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/27/1981N16053000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 3/16/2007
AP05/12/1981SCP       
AP05/12/1981SCF       
AP06/26/1981SCM       
AP03/25/1982SCP       
AP010/25/1982SCM       
AP010/25/1991SE1       
AP012/11/1984SCP       
AP08/22/1985SCS       
AP07/22/1985SCM       
AP05/16/1986SCS       
AP04/22/1986SCP       
AP04/9/1987SCM       
AP04/10/1987SLR       
AP09/2/1987SCP       
AP010/25/1991SE1       
AP01/22/1990SLR       
AP02/16/1990SCP       
AP01/22/1990SLR       
AP06/28/1989SCM       
AP02/16/1990SCP       
AP03/14/1990SCS       
AP07/19/1994SLR       
AP02/28/1994SCS       
AP03/29/1994SLR       
AP04/11/2000SLR       
AP04/21/1993SCP       
AP03/17/1994SCS       
AP04/15/1992SCS       
AP04/16/1992SLR       
AP07/13/1994SCP       
AP07/13/1994SCP       
AP08/10/1992SLR       
AP07/23/1993SCP       
AP011/25/1992SLR       
AP07/15/1994SCS       
AP02/2/1993SLR       
AP06/15/1993SCP       
AP02/27/1995SCS       
AP012/13/1994SCS       
AP04/11/2000SLR       
AP012/18/1995SCS       
AP012/7/1995SCM       
AP04/15/1999SCP       
AP010/27/1999SCM       
AP05/31/2002SLR3160053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18163s053ltr.pdf 6/3/2002
AP011/8/2010SLR26928054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018163s054ltr.pdf 11/12/2010
AP011/8/2010SLR26945054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018163s054lbl.pdf 11/12/2010
AP011/2/2004SCM10536057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18163s057ltr.pdf 11/8/2004
AP02/25/2008SLR19297058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf 2/26/2008
AP02/25/2008SLR19304058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018163s058, s059ltr.pdf 2/27/2008
AP02/25/2008SLR19305059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018163s058, s059ltr.pdf 2/27/2008
AP02/25/2008SLR19298059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018163s058s059lbl.pdf 2/26/2008




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