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FDA Drug Application 050522 by LILLY

Application Number050522
Application Type New Drug Application
Sponsor ApplicantLILLY
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/4/1979N       
AP07/14/1986SLR       
AP08/28/1986SLR       
AP07/21/1988SLR       
AP05/1/1996SLR       
AP05/1/1996SLR       
AP012/8/1992SCS       
AP04/13/1995SLR       
AP05/28/1993SLR       
AP03/6/1996SLR       
AP09/30/1996SLR       
AP03/5/1996SLR       
AP02/2/1998SLR2318018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050521s021_ceclor.pdf 2/2/1998
AP09/18/1998SLR       
AP03/16/2000SCM       
AP03/13/2000SCS       
AP04/27/2000SCS       
AP010/12/2001SLR       
AP03/3/2003SLR4241024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50521slr026,50522slr024ltr.pdf 3/10/2003
AP03/17/2004SLR8002027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50521slr027,50522slr027ltr.pdf 3/24/2004
AP03/17/2004SLR8219027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50521slr027,50522slr027_cefaclor_lbl.pdf 4/5/2004




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