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FDA Drug Application 020611 by LEO PHARM

Application Number020611
Application Type New Drug Application
Sponsor ApplicantLEO PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/3/1997N4279000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020611ap.pdf 3/3/1997
AP07/31/1998SCS       
AP03/11/1999SCM       
AP01/11/2000SLR       
AP04/28/2005SLR11552006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020611s006ltr.pdf 5/2/2005
AP04/28/2005SLR11559006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020611s006lbl.pdf 5/2/2005
AP09/26/2007SLR18144007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020611s007,020554s007,020273s009ltr.pdf 10/4/2007
AP09/26/2007SLR18174007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020611s007,020554s007,020273s009lbl.pdf 10/4/2007




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