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FDA Drug Application 021539 by CUMBERLAND PHARMS

Application Number021539
Application Type New Drug Application
Sponsor ApplicantCUMBERLAND PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/23/2004N7635000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539ltr.pdf 2/2/2004
AP01/23/2004N7663000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539_N-acetylcysteine_lbl.pdf 2/3/2004
AP01/23/2004N10434000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-539_Acetadote.cfm 10/18/2004
AP04/28/2004SLR8410001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539slr001ltr.pdf 4/29/2004
AP04/28/2004SLR8503001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539slr001_acetadote_lbl.pdf 5/4/2004
AP04/28/2004SLR8457002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21539slr002ltr.pdf 5/3/2004
AP04/28/2004SLR8504002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21539slr002_acetadote_lbl.pdf 5/4/2004
AP02/14/2006SLR13636004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021539s004lbl.pdf 2/22/2006
AP02/14/2006SLR13648004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021539s004ltr.pdf 2/22/2006
AP012/12/2008SLR21372005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021539s005ltr.pdf 12/19/2008
AP01/7/2011SCM       
AP06/5/2013SLR36234012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021539Orig1s012ltr.pdf 6/6/2013
AP06/5/2013SLR36270012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021539s012lbl.pdf 6/11/2013
AP01/15/2013SCM       
AP07/29/2016SLR46699015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021539s015lbl.pdf 8/2/2016
AP07/29/2016SLR46707015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021539Orig1s015ltr.pdf 8/2/2016




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