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FDA Drug Application 020073 by HOFFMANN LA ROCHE

Application Number020073
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/1991N       
AP09/11/1992SCS       
AP012/15/1992SLR       
AP010/24/1995SLR       
AP05/10/1995SLR       
AP011/29/1994SCS       
AP012/5/1994SCS       
AP07/12/1994SLR       
AP09/21/1998SLR       
AP011/14/1997SCS       
AP05/22/2000SLR       
AP03/3/2004SLR7832011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020073s011lbl.pdf 3/5/2004
AP03/3/2004SLR7860011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20073slr011ltr.pdf 3/10/2004
AP06/6/2001SCS       
AP011/12/2002SCS       
AP010/4/2007SLR18207016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020073s016ltr.pdf 10/10/2007
AP010/4/2007SLR18220016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020073s016lbl.pdf 10/10/2007




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