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FDA Drug Application 010775 by SCHERING

Application Number010775
Application Type New Drug Application
Sponsor ApplicantSCHERING
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/27/1957N       
AP03/29/1982SLR       
AP010/20/1995SCS       
AP08/21/1998SCS       
AP06/1/2000SCF       
AP04/7/1999SCS       
AP03/3/2000SCS       
AP03/15/2001SLR1610029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10775S29ltr.pdf 3/15/2001
AP03/15/2001SLR4049029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/10-775SLR029.pdf 2/4/2003
AP010/18/2001SLR       
AP05/10/2002SLR17108031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/010775_S031_TRILAFON_AP.pdf 7/6/2007
AP05/10/2002SLR4045031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10775s031ltr.pdf 5/10/2002
AP05/10/2002SLR4048031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/10775s311213s24lbl.pdf 5/10/2002




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