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FDA Drug Application 070434 by ROXANE

Application Number070434
Application Type Abbreviated New Drug Application
Sponsor ApplicantROXANE
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
AP04/22/1987N       
AP07/12/1988SC       
AP07/12/1988SL       
AP07/12/1988SC       
AP07/12/1988SC       
AP05/26/1989SL       
AP010/21/1988SC       
AP010/21/1988SC       
AP111/10/1988SB       
AP210/21/1988SC       
AP012/28/1989SL       
AP012/4/1990SL       
AP02/14/1992SC       
AP08/28/1992SL       
AP06/24/1994SL       
AP04/21/1997SC       
AP04/21/1997SC       
AP04/21/1997SC       
AP04/21/1997SC       
AP04/21/1997SL       
AP08/28/1996SC       
AP09/22/2000SCC       
AP09/22/2000SCA       
AP011/30/2000SCP       
AP011/30/2000SCS       
AP05/23/2002SCB       
AP05/11/2012SLR36958032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/070434s032lbl.pdf 9/6/2013




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