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FDA Drug Application 005378 by RECORDATI RARE

Application Number005378
Application Type New Drug Application
Sponsor ApplicantRECORDATI RARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1943N23947000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088582.pdf 11/18/2009
AP012/31/1943N31037000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 12/20/2011
AP07/22/1975SLR       
AP07/22/1975SCS       
AP07/22/1975SLR       
AP03/30/1979SLR       
AP09/30/1981SCM       
AP02/22/1984SLR       
AP09/22/1982SCM       
AP06/27/1983SLR       
AP04/25/1983SLR       
AP07/27/1989SCM       
AP012/6/2001SLR4849020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/05378s20ltr.pdf 4/3/2003
AP05/13/1998SCP       
AP06/16/1999SCS       
AP011/20/2000SCM       
AP04/12/2006SLR13922024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/005378s024lbl.pdf 4/13/2006
AP04/12/2006SLR13927024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/05378s024ltr.pdf 4/13/2006
AP05/11/2007SLR16565026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/005378s026ltr.pdf 5/16/2007
AP05/11/2007SLR16572026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005378s026lbl.pdf 5/16/2007
AP08/23/2013SLR36893027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/0005378s027lbl.pdf 8/27/2013
AP08/23/2013SLR36897027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s027ltr.pdf 8/27/2013
AP012/3/2013SLR37961028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/005378s028lbl.pdf 12/4/2013
AP012/3/2013SLR37983028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s028ltr.pdf 12/9/2013
AP01/26/2015SCM       
AP04/17/2015SLR42571030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/005378s030lbl.pdf 4/20/2015
AP04/17/2015SLR42591030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/005378Orig1s030ltr.pdf 4/21/2015




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