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FDA Drug Application 050537 by PHARMACIA AND UPJOHN

Application Number050537
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
AP07/9/1980N       
AP08/14/1980SLR       
AP09/15/1980SCM       
AP09/30/1980SCM       
AP03/2/1983SLR       
AP07/18/1986SLR       
AP08/6/1984SLR       
AP01/23/1986SCS       
AP05/11/1981SLR       
AP04/20/1981SLR       
AP03/15/1989SLR       
AP07/28/1989SCP       
AP07/14/2002SLR2484013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50537slr013,50600slr002,50615slr003ltr.pdf 7/14/2002
AP07/14/2002SLR2485013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50537s13lbl.pdf 7/14/2002
AP02/22/1994SCS       
AP012/21/1992SCP       
AP011/18/1981SLR       
AP011/23/1981SLR       
AP02/25/1982SLR       
AP08/21/1981SCE       
AP09/5/1994SCM       
AP06/7/1999SCM       
AP05/30/2003SLR5842026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50537slr026,50600slr007,50615slr005ltr.pdf 6/8/2003
AP05/30/2003SLR5891026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50537slr026,50600slr007,50615slr005_cleocin_lbl.pdf 6/8/2003
AP04/4/2014SLR38988035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050600Orig1s013,050537Orig1s035,050615Orig1s012ltr.pdf 4/7/2014
AP04/4/2014SLR39004035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050537s035,050600s013,050615s012lbl.pdf 4/8/2014
AP08/29/2014SCM       
AP01/15/2016SLR44989037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050537s037,050600s014,050615s014ltr.pdf 1/20/2016
AP01/15/2016SLR45030037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050537s037,050600s014,050615s014lbl.pdf 1/26/2016




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