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FDA Drug Application 017243 by MALLINKRODT NUCLEAR

Application Number017243
Application Type New Drug Application
Sponsor ApplicantMALLINKRODT NUCLEAR
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
AP011/23/1973N       
AP010/8/1976SCP       
AP07/27/1977SCM       
AP08/23/1977SCM       
AP07/24/1979SCP       
AP05/7/1982SCS       
AP06/30/1982SCP       
AP03/26/1984SPD       
AP07/16/1996SCS       
AP03/21/1997SCS       
AP08/20/1996SCS       
AP06/18/1997SCM       
AP02/18/1998SLR       
AP011/20/1998SCM       
AP04/14/1999SCS       
AP012/29/1999SCF       
AP03/4/2002SCS       
AP04/19/2002SCM       
AP01/16/2003SCS9602022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17243scs022ltr.pdf 6/29/2004
AP010/15/2004SCS10450025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17243s025ltr.pdf 10/22/2004
AP010/15/2004SCS10453025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf 10/22/2004
AP03/27/2006SLR13853028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017243s028ltr.pdf 4/5/2006
AP06/21/2013SCM       
AP05/13/2013SCM       
AP05/10/2013SCM       
AP03/15/2013SCM       
AP06/11/2013SCM       
AP011/18/2013SCM       
AP02/18/2014SLR38532043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017243Orig1s043ltr.pdf 2/19/2014
AP02/18/2014SLR38537043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf 2/19/2014
AP012/20/2013SLR38152044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017243Orig1s044ltr.pdf 12/24/2013
AP012/20/2013SLR38255044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf 1/13/2014
AP02/16/2015SCM       
AP05/4/2015SLR42733046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017243Orig1s046ltr.pdf 5/5/2015
AP05/4/2015SLR42743046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf 5/6/2015




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