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FDA Drug Application 050615 by PHARMACIA AND UPJOHN

Application Number050615
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
AP01/7/1987N       
AP07/14/2002SLR2488003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr002,50615slr003ltr.pdf 7/14/2002
AP07/14/2002SLR2489003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf 7/14/2002
AP01/27/1998SCS       
AP05/30/2003SLR5844005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr007,50615slr005ltr.pdf 6/8/2003
AP05/30/2003SLR5893005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf 6/8/2003
AP04/4/2014SLR38989012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537Orig1s035,050615Orig1s012ltr.pdf 4/7/2014
AP04/4/2014SLR39002012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf 4/8/2014
AP01/12/2015SCM       
AP01/15/2016SLR44991014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,050615s014ltr.pdf 1/20/2016
AP01/15/2016SLR45032014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf 1/26/2016




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