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FDA Drug Application 022430 by FERRING PHARMS AS

Application Number022430
Application Type New Drug Application
Sponsor ApplicantFERRING PHARMS AS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/13/2009N23921000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022430lbl.pdf 11/17/2009
AP011/13/2009N23977000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022430s000ltr.pdf 11/19/2009
AP011/13/2009N25471000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430_lysteda_toc.cfm 5/6/2010
AP011/13/2009N25472000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022430s000sumr.pdf 5/6/2010
AP04/6/2011SLR28486002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022430s002lbl.pdf 4/7/2011
AP04/6/2011SLR28512002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022430s002ltr.pdf 4/11/2011
AP04/6/2011SLR30817002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/022430Orig1s002.pdf 10/10/2011
AP08/21/2013SLR36873003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s003lbl.pdf 8/22/2013
AP08/21/2013SLR36877003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s003ltr.pdf 8/22/2013
AP010/3/2013SLR37366004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022430Orig1s004ltr.pdf 10/4/2013
AP010/3/2013SLR37387004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022430s004lbl.pdf 10/8/2013
AP010/23/2015SCM       
AP05/23/2016SCM       




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