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FDA Drug Application 022571 by MERZ PHARMS

Application Number022571
Application Type New Drug Application
Sponsor ApplicantMERZ PHARMS
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
AP07/28/2010N26066000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022571s000lbl.pdf 7/31/2010
AP07/28/2010N26087000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022571s000ltr.pdf 8/2/2010
AP07/28/2010N27939000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571s000_cuvposa_toc.cfm 2/23/2011
AP07/28/2010N27940000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571Orig1s000SumR.pdf 2/23/2011
AP011/8/2012SCM       
AP05/21/2013SLR36126003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022571Orig1s003ltr.pdf 5/23/2013
AP05/21/2013SLR36132003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022571s003lbl.pdf 5/23/2013
AP011/6/2015SLR44453004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022571s004lbl.pdf 11/12/2015
AP011/6/2015SLR44465004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022571Orig1s004ltr.pdf 11/13/2015
AP02/8/2016SCM       
AP05/18/2016SLR46076006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022571Orig1s006ltr.pdf 5/20/2016
AP05/18/2016SLR46097006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022571s006lbl.pdf 5/20/2016




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