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FDA Drug Application 050664 by CORDEN PHARMA

Application Number050664
Application Type New Drug Application
Sponsor ApplicantCORDEN PHARMA
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
AP012/23/1991N       
AP012/31/1992SE5       
AP05/17/1995SE5       
AP07/23/1993SCS       
AP08/31/1995SLR       
AP08/31/1995SLR       
AP03/21/1994SCM       
AP07/6/1994SCM       
AP011/10/1994SCM       
AP02/8/1995SLR       
AP04/10/1995SCS       
AP012/26/1995SLR       
AP09/5/1996SE1       
AP08/26/1997SLR       
AP04/23/1997SLR       
AP05/29/1997SLR       
AP011/6/1998SCS       
AP02/18/1999SCS       
AP010/1/2001SLR       
AP08/10/2000SCS       
AP04/19/2001SCS       
AP06/23/2004SLR9536023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50664slr023,50665slr023ltr.pdf 6/25/2004
AP06/23/2004SLR9557023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf 6/25/2004
AP09/14/2007SLR17900024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf 9/19/2007
AP09/14/2007SLR17987024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050664s024, 050665s024ltr.pdf 9/25/2007




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