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FDA Drug Application 204141 by TARO

Application Number204141
Application Type New Drug Application
Sponsor ApplicantTARO
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
AP04/11/2013N35696000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204141Orig1s000ltr.pdf 4/16/2013
AP04/11/2013N35716000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204141s000lbl.pdf 4/16/2013
AP04/11/2013N37689000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141_topicort_toc.cfm 11/5/2013
AP04/11/2013N37690000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204141Orig1s000SumR.pdf 11/5/2013
AP07/18/2014SCM       
AP09/10/2015SCM       
AP09/23/2015SCM       
AP012/16/2015SLR44788004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204141Orig1s004ltr.pdf 12/17/2015
AP012/16/2015SLR44805004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204141s004lbl.pdf 12/17/2015




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