Back to FDA Applications sponsored by LUPIN LTD

FDA Drug Application 202091 by LUPIN LTD

Application Number202091
Application Type New Drug Application
Sponsor ApplicantLUPIN LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/20/2013N35209000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202091Orig1s000ltr.pdf 2/21/2013
AP02/20/2013N35212000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202091s000lbl.pdf 2/21/2013
AP02/20/2013N38232000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000TOC.cfm 1/8/2014
AP02/20/2013N38233000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202091Orig1s000SumR.pdf 1/8/2014
AP01/16/2014SCM       
AP05/29/2014SLR39420002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202091Orig1s002ltr.pdf 6/2/2014
AP05/29/2014SLR39445002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202091Orig1s002lbl.pdf 6/4/2014
AP05/10/2016SCM       
AP01/7/2016SLR44945004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202091Orig1s004,203195Orig1s005ltr.pdf 1/11/2016
AP01/7/2016SLR44957004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202091s004,203195s005lbl.pdf 1/12/2016




Back to FDA Applications sponsored by LUPIN LTD