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FDA Drug Application 050780 by B BRAUN

Application Number050780
Application Type New Drug Application
Sponsor ApplicantB BRAUN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/21/2001N2338000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_approv.pdf 2/21/2001
AP02/21/2001N2339000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime_prntlbl.pdf 2/21/2001
AP02/21/2001N2340000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50780_Cefuroxime.cfm 2/21/2001
AP08/18/2003SLR6585005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50780slr005ltr.pdf 8/29/2003
AP06/29/2004SLR9695006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50780slr006ltr.pdf 7/1/2004
AP05/6/2005SLR11630008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050780s008ltr.pdf 5/17/2005
AP09/10/2007SLR17834011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050780s011lbl.pdf 9/11/2007
AP09/10/2007SLR17846011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050780s011ltr.pdf 9/11/2007
AP012/12/2013SCM       
AP05/1/2015SLR42715019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050780Orig1s019ltr.pdf 5/4/2015
AP05/1/2015SLR42724019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050780s019lbl.pdf 5/4/2015




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