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FDA Drug Application 020947 by NUVO RES INC

Application Number020947
Application Type New Drug Application
Sponsor ApplicantNUVO RES 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
AP011/4/2009N23847000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020947lbl.pdf 11/12/2009
AP011/4/2009N23868000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020947s000ltr.pdf 11/13/2009
AP011/4/2009N23938000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM191085.pdf 11/18/2009
AP011/4/2009N25473000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020947_pennsaid_toc.cfm 5/6/2010
AP011/4/2009N25474000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020947s000sumr.pdf 5/6/2010
AP03/25/2010SLR25151001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020947s001s002ltr.pdf 3/31/2010
AP03/25/2010SLR25203001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf 4/4/2010
AP03/25/2010SLR25204002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020947s001s002lbl.pdf 4/4/2010
AP03/25/2010SLR25152002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020947s001s002ltr.pdf 3/31/2010
AP07/14/2011SLR29521007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020947s007ltr.pdf 7/18/2011
AP010/21/2013SLR37496008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020947s008lbl.pdf 10/21/2013
AP010/21/2013SLR37542008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020947Orig1s008ltr.pdf 10/24/2013
AP05/9/2016SLR45921010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020947Orig1s010,s011ltr.pdf 5/11/2016
AP05/9/2016SLR45971010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020947s010s011lbl.pdf 5/11/2016
AP05/9/2016SLR45972011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020947s010s011lbl.pdf 5/11/2016
AP05/9/2016SLR45922011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020947Orig1s010,s011ltr.pdf 5/11/2016




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