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FDA Drug Application 203195 by LUPIN LTD

Application Number203195
Application Type New Drug Application
Sponsor ApplicantLUPIN LTD
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
AP06/1/2012N32813000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203195s000lbl.pdf 6/5/2012
AP06/1/2012N32838000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203195s000ltr.pdf 6/7/2012
AP06/1/2012N34410000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203195_suprax_toc.cfm 11/16/2012
AP06/1/2012N34411000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203195Orig1s000SumR.pdf 11/16/2012
AP03/26/2013SCM35598001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203195s001lbl.pdf 4/1/2013
AP09/18/2013SCM       
AP011/22/2013SCM       
AP01/7/2016SLR44944005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202091Orig1s004,203195Orig1s005ltr.pdf 1/11/2016
AP01/7/2016SLR44958005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202091s004,203195s005lbl.pdf 1/12/2016




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