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FDA Drug Application 202342 by HANMI PHARM CO LTD

Application Number202342
Application Type New Drug Application
Sponsor ApplicantHANMI PHARM CO LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA04/29/2013TA35898000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000TAltr.pdf 5/1/2013
AP18/6/2013N35898000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000TAltr.pdf 5/1/2013
TA04/29/2013TA36727000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000ltr.pdf 8/8/2013
AP18/6/2013N36727000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000ltr.pdf 8/8/2013
TA04/29/2013TA36760000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202342s000lbl.pdf 8/9/2013
AP18/6/2013N36760000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202342s000lbl.pdf 8/9/2013
TA04/29/2013TA37805000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202342Orig1s000TOC.cfm 11/13/2013
AP18/6/2013N37805000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202342Orig1s000TOC.cfm 11/13/2013
AP012/19/2014SLR41364002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202342Orig1s002ltr.pdf 12/23/2014
AP012/19/2014SLR41425002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202342s002lbl.pdf 12/29/2014
AP010/24/2016SLR47440003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202342Orig1s003ltr.pdf 10/26/2016
AP010/24/2016SLR47516003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202342s003lbl.pdf 10/28/2016




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