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FDA Drug Application 017422 by EMCURE PHARMS LTD

Application Number017422
Application Type New Drug Application
Sponsor ApplicantEMCURE PHARMS LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/7/1977N       
AP012/22/1977SLR       
AP09/15/1978SCM       
AP010/9/1979SCS       
AP010/9/1979SLR       
AP011/12/1980SLR       
AP04/3/1984SCE       
AP02/16/1982SLR       
AP04/21/1987SPD       
AP02/10/1983SCM       
AP02/17/1984SCS       
AP06/29/1983SLR       
AP03/13/1984SCS       
AP08/8/1984SCS       
AP012/10/1984SCS       
AP07/11/1986SLR       
AP05/19/1986SLR       
AP05/19/1986SLR       
AP05/19/1986SLR       
AP03/5/1987SCM       
AP08/7/1987SCS       
AP010/26/1987SLR       
AP01/12/1988SCS       
AP05/17/1988SCS       
AP04/19/1989SCM       
AP09/14/1989SCS       
AP01/3/1991SCP       
AP06/13/1991SCS       
AP012/11/1992SLR       
AP07/13/1992SCS       
AP09/10/1997SLR       
AP02/27/2003SLR4260035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17422slr035ltr.pdf 3/10/2003
AP010/20/2005SCS12964036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/017422s036ltr.pdf 10/25/2005
AP08/17/2007SCM17660037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017422s037lbl.pdf 8/21/2007
AP08/17/2007SCM17687037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017422s037ltr.pdf 8/22/2007
AP08/17/2007SCM41703037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/017422Orig1s037.pdf 1/28/2015
AP03/14/2011SLR28250038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s038lbl.pdf 3/14/2011
AP03/14/2011SLR28252038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017422s038ltr.pdf 3/16/2011
AP08/11/2011SLR29778042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017422s042lbl.pdf 8/12/2011
AP08/11/2011SLR29788042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017422s042ltr.pdf 8/15/2011
AP09/18/2013SCM43690045   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/017422Orig1s045.pdf 8/21/2015
AP010/18/2013SLR37518046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017422s046lbl.pdf 10/22/2013
AP06/13/2014SCM43691047   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/017422Orig1s047.pdf 8/21/2015
AP011/25/2015SCM       
AP04/28/2016SLR45813050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017422Orig1s050ltr.pdf 5/2/2016
AP04/28/2016SLR46344050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017422Orig2s050Lbl.pdf 6/17/2016
AP09/20/2016SCM       
AP010/6/2016SCM       
AP09/19/2016SCM       




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