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FDA Drug Application 020623 by US PHARM HOLDINGS

Application Number020623
Application Type New Drug Application
Sponsor ApplicantUS PHARM HOLDINGS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/11/1997N24942000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020623_anzemet_toc.cfm 3/3/2010
AP010/17/1997SLR       
AP01/25/1999SLR       
AP03/16/1999SCM       
AP06/1/2005SLR11747004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020623s004ltr.pdf 6/7/2005
AP06/1/2005SLR11770004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020623s004lbl.pdf 6/7/2005
AP05/30/2007SLR16677006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s006,020624s016ltr.pdf 6/4/2007
AP05/30/2007SLR16697006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.pdf 6/4/2007
AP09/24/2007SLR18049007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s007, 020624s017ltr.pdf 9/26/2007
AP010/6/2009SLR23569008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020623s008lbl.pdf 10/14/2009
AP010/6/2009SLR23807008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020623s008ltr.pdf 11/10/2009
AP09/22/2011SLR30084009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020623s009ltr.pdf 9/27/2011
AP09/22/2011SLR30099009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020623s009lbl.pdf 9/28/2011
AP09/16/2013SLR37100010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020623s010lbl.pdf,020624s023lbl.pdf 9/16/2013
AP09/16/2013SLR37105010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020623Orig1s010,020624Orig1s023ltr.pdf 9/17/2013
AP08/6/2013SCM       
AP19/20/2013SCM       
AP09/18/2014SLR40540012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020623s012lbl.pdf 9/22/2014
AP09/18/2014SLR40553012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020623Orig1s012ltr.pdf 9/23/2014
AP09/20/2016SCM       




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