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FDA Drug Application 008578 by TURING PHARMS AG

Application Number008578
Application Type New Drug Application
Sponsor ApplicantTURING PHARMS AG
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
AP01/23/1953N       
AP02/20/1987SPD       
AP010/17/1988SLR       
AP04/8/1998SLR       
AP03/25/1997SLR       
AP04/8/1998SLR       
AP010/10/2002SLR1641015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf 10/10/2002
AP010/10/2002SLR8881015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8578slr015ltr.pdf 6/2/2004
AP011/18/2003SLR6925016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08578slr016ltr.pdf 11/25/2003
AP011/18/2003SLR7002016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf 12/1/2003




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