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FDA Drug Application 203098 by PERRIGO ISRAEL

Application Number203098
Application Type New Drug Application
Sponsor ApplicantPERRIGO ISRAEL
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
AP01/31/2013N35044000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203098s000lbl.pdf 2/1/2013
AP01/31/2013N35054000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203098Orig1s000ltr.pdf 2/4/2013
AP01/31/2013N36400000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203098Orig1s000TOC.cfm 6/28/2013
AP01/31/2013N36401000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203098Orig1s000SumR.pdf 6/28/2013
AP01/31/2013N43259000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=317 7/7/2015
AP05/1/2015SCM       
AP06/19/2014SLR39607002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203098Orig1s002ltr.pdf 6/23/2014
AP06/19/2014SLR39631002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203098s002lbl.pdf 6/23/2014
AP02/3/2015SCM       
AP05/11/2015SLR42790006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203098Orig1s006ltr.pdf 5/13/2015
AP05/11/2015SLR42803006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203098s006lbl.pdf 5/13/2015
AP02/26/2016SCM       
AP09/29/2016SCM       
AP010/25/2016SLR47483009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203098Orig1s009ltr.pdf 10/27/2016




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