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FDA Drug Application 022348 by CUMBERLAND PHARMS

Application Number022348
Application Type New Drug Application
Sponsor ApplicantCUMBERLAND PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/11/2009N22761000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022348s000ltr.pdf 6/17/2009
AP06/11/2009N22784000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022348lbl.pdf 6/22/2009
AP06/11/2009N25027000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022348_caldolor_toc.cfm 3/11/2010
AP06/11/2009N25028000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022348s000SumR.pdf 3/11/2010
AP01/14/2014SCM       
AP01/27/2015SLR41708003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022348Orig1s003ltr.pdf 1/28/2015
AP03/9/2015SCM       
AP011/20/2015SE844559005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022348Orig1s005ltr.pdf 11/23/2015
AP011/20/2015SE844582005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022348s005lbl.pdf 11/25/2015
AP05/9/2016SLR45909010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022348Orig1s010ltr.pdf 5/11/2016
AP05/9/2016SLR45982010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022348s010lbl.pdf 5/11/2016




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