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FDA Drug Application 050624 by HOFFMANN LA ROCHE

Application Number050624
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
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
AP02/11/1987N       
AP05/22/1987SLR       
AP06/22/1987SLR       
AP06/18/1987SLR       
AP06/18/1987SLR       
AP04/15/1991SCP       
AP03/11/1991SLR       
AP011/14/1988SLR       
AP03/11/1991SLR       
AP03/11/1991SLR       
AP03/11/1991SLR       
AP010/7/1993SLR       
AP010/7/1993SLR       
AP03/1/1993SCS       
AP012/4/1992SLR       
AP04/26/1994SLR       
AP02/22/1993SLR       
AP08/18/1994SLR       
AP010/20/1993SLR       
AP07/21/1997SCM       
AP010/18/1999SCS       
AP011/21/2001SLR       
AP09/2/2004SLR10110026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s056,50624s026lbl.pdf 9/3/2004
AP09/2/2004SLR10117026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s056,50624s026ltr.pdf 9/3/2004
AP09/14/2004S10193027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s057,50624s027lbl.pdf 9/15/2004
AP09/14/2004S10194027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s057,50624s027ltr.pdf 9/15/2004




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