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FDA Drug Application 202763 by ANI PHARMS INC

Application Number202763
Application Type New Drug Application
Sponsor ApplicantANI PHARMS INC
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
AP02/14/2012N31808000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202763s000ltr.pdf 2/17/2012
AP02/14/2012N31828000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202763s000mg.pdf 2/17/2012
AP02/14/2012N31829000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202763s000lbl.pdf 2/17/2012
AP02/14/2012N32033000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=57 3/6/2012
AP02/14/2012N32460000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202763Orig1s000TOC.cfm 4/17/2012
AP02/14/2012N32461000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202763Orig1s000SumR.pdf 4/17/2012
AP07/23/2014SLR39978001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202763s001lbl.pdf 7/24/2014
AP07/23/2014SLR39996001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202763Orig1s001ltr.pdf 7/24/2014
AP06/19/2014SLR39608002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202763Orig1s002ltr.pdf 6/23/2014
AP06/19/2014SLR39630002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202763s002lbl.pdf 6/23/2014
AP05/11/2015SLR42789003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202763Orig1s003ltr.pdf 5/13/2015
AP05/11/2015SLR42802003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202763s003lbl.pdf 5/13/2015
AP010/25/2016SLR47482004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202763Orig1s004ltr.pdf 10/27/2016




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