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FDA Drug Application 050521 by LILLY

Application Number050521
Application Type New Drug Application
Sponsor ApplicantLILLY
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
AP04/4/1979N       
AP05/1/1996SLR       
AP05/1/1996SLR       
AP011/8/1991SCS       
AP03/10/1994SCS       
AP011/8/1991SCS       
AP05/28/1993SLR       
AP04/13/1995SLR       
AP03/6/1996SLR       
AP09/30/1996SLR       
AP02/2/1998SLR500021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050521s021_ceclor.pdf 2/2/1998
AP09/18/1998SLR       
AP07/29/1999SCM       
AP03/13/2000SCS       
AP04/27/2000SCS       
AP03/3/2003SLR4240026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50521slr026,50522slr024ltr.pdf 3/10/2003
AP03/17/2004SLR8001027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50521slr027,50522slr027ltr.pdf 3/24/2004
AP03/17/2004SLR8218027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50521slr027,50522slr027_cefaclor_lbl.pdf 4/5/2004




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