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FDA Drug Application 125294 by SICOR BIOTECH

Application Number125294
Application Type Biologic License Application
Sponsor ApplicantSICOR BIOTECH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/29/2012N336170000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125294s0000lbl.pdf 8/31/2012
AP08/29/2012N336300000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125294Orig1s000ltr.pdf 9/4/2012
AP08/29/2012N338490000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000TOC.cfm 9/26/2012
AP08/29/2012N338500000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125294Orig1s000SumR.pdf 9/26/2012
AP07/19/2013SLR36583007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125294Orig1s007ltr.pdf 7/22/2013
AP07/19/2013SLR36586007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125294s007lbl.pdf 7/23/2013
AP012/19/2014SLR41349035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125294s035lbl.pdf 12/22/2014




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