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FDA Drug Application 203585 by IVAX INTL

Application Number203585
Application Type New Drug Application
Sponsor ApplicantIVAX INTL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/26/2012N34178000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203585lbl.pdf 10/26/2012
AP010/26/2012N34191000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203585Orig1s000ltr.pdf 10/29/2012
AP010/26/2012N34479000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203585Orig1s000TOC.cfm 11/28/2012
AP010/26/2012N34480000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203585Orig1s000SumR.pdf 11/28/2012
AP02/10/2014SE838499001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s001lbl.pdf 2/11/2014
AP02/10/2014SE838506001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203585Orig1s001ltr.pdf 2/12/2014
AP011/22/2013SCM       
AP05/1/2014SLR39195003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s003lbl.pdf 5/2/2014
AP05/1/2014SLR39212003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203585Orig1s003ltr.pdf 5/6/2014
AP05/1/2014SLR39293003   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM396919.pdf 5/12/2014
AP06/13/2016SLR46333004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203585Orig1s004ltr.pdf 6/15/2016
AP06/13/2016SLR46351004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203585s004lbl.pdf 6/17/2016




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