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FDA Drug Application 022276 by EXELA PHARMA SCIENCE

Application Number022276
Application Type New Drug Application
Sponsor ApplicantEXELA PHARMA SCIENCE
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
AP07/24/2008N20312000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022276lbl.pdf 7/29/2008
AP07/24/2008N20348000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022276s000ltr.pdf 7/31/2008
AP07/24/2008N20991000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000TOC.cfm 10/9/2008
AP07/24/2008N20992000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000_SumR.pdf 10/9/2008
AP01/8/2009SLR21559003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022276s003ltr.pdf 1/12/2009
AP01/8/2009SLR21634003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022276s003lbl.pdf 1/14/2009
AP01/10/2013SCM       
AP04/7/2016SCM45626008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s008lbl.pdf 4/8/2016
AP04/7/2016SCM45633008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s008ltr.pdf 4/11/2016
AP010/28/2014SCM       
AP09/23/2016SLR47162011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s011ltr.pdf 9/26/2016
AP09/23/2016SLR47196011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s011lbl.pdf 9/29/2016




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