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FDA Drug Application 050680 by PHARMACIA AND UPJOHN

Application Number050680
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/11/1992N       
AP010/5/1995SE1       
AP03/2/1998SE285002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050680S002.cfm 3/2/1998
AP03/2/1998SE24622002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050680s002_appltr.pdf 3/2/1998
AP08/5/1996SCP       
AP08/20/2003SLR6586004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50680slr004ltr.pdf 8/29/2003
AP08/20/2003SLR6590004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50680slr004_cleocin_lbl.pdf 8/29/2003
AP05/9/2014SLR39266010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050680s010,050767s011lbl.pdf 5/12/2014
AP05/9/2014SLR39290010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050680Orig1s010,050767Orig1s011ltr.pdf 5/12/2014
AP07/13/2015SLR43373011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050680Orig1s011,050767Orig1s012ltr.pdf 7/15/2015
AP07/13/2015SLR43391011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050680s011,050767s012lbl.pdf 7/16/2015




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