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FDA Drug Application 125360 by MERZ PHARMS

Application Number125360
Application Type Biologic License Application
Sponsor ApplicantMERZ PHARMS
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
AP07/30/2010N26218000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM222360.pdf 8/16/2010
AP07/30/2010N26581000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125360s0000TOC.cfm 9/29/2010
AP07/30/2010N27919000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125360s000SumR.pdf 2/17/2011
AP07/30/2010N26110000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf 8/6/2010
AP07/30/2010N26114000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125360s000,s001ltr.pdf 8/6/2010
AP07/30/2010S26115001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125360s000,s001ltr.pdf 8/6/2010
AP07/30/2010S26111001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125360lbl.pdf 8/6/2010
AP07/20/2011S29595007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125360s007MedG.pdf 7/25/2011
AP07/20/2011S29596007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125360s007lbl.pdf 7/25/2011
AP07/16/2012SLR33225040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125360Orig1s040ltr.pdf 7/18/2012
AP04/11/2013SLR35699045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125360Orig1s045ltr.pdf 4/16/2013
AP04/11/2013SLR35720045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125360s045lbl.pdf 4/16/2013
AP011/20/2015SCM44591066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125360s066lbl.pdf 11/25/2015
AP012/22/2015SE844880067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125360s067lbl.pdf 12/28/2015
AP012/22/2015SE844899067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125360Orig1s067ltr.pdf 12/29/2015




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