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FDA Drug Application 019979 by ROCHE PALO

Application Number019979
Application Type New Drug Application
Sponsor ApplicantROCHE PALO
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
AP010/31/1991N       
AP05/5/1994SCM       
AP012/10/1992SLR       
AP012/16/1992SLR       
AP03/24/1993SCM       
AP01/25/1995SCM       
AP01/25/1995SLR       
AP010/18/1996SCM       
AP02/24/1997SCM       
AP08/21/1997SCP       
AP04/27/1998SCM       
AP02/3/1998SCS       
AP07/28/1999SLR       
AP04/18/2001SE13971018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-879S018_Ticlid.cfm 12/18/2001
AP04/18/2001SE15014018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19979S18ltr.pdf 4/18/2001
AP04/18/2001SE15119018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-979S018_Ticlid_prntlbl.pdf 4/18/2001
AP06/14/2000SLR3970019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19979-s019_ticlid.pdf 6/4/2001
AP011/9/2001SCP       




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