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FDA Drug Application 020624 by US PHARM HOLDINGS

Application Number020624
Application Type New Drug Application
Sponsor ApplicantUS PHARM HOLDINGS
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
AP09/11/1997N4770000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020624_anzemet_toc.cfm 10/20/1998
AP010/17/1997SLR       
AP01/25/1999SLR       
AP02/13/2003SCF8749003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20624scf003ltr.pdf 5/27/2004
AP01/26/1999SCM       
AP04/26/2000SCM       
AP012/11/2001SCS       
AP05/24/2002SCP       
AP03/22/2002SLR4455008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20624s8ltr.pdf 3/22/2002
AP03/22/2002SLR16980008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020624_S008_AMZEMET_AP.pdf 7/6/2007
AP07/18/2003SCS6172009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20624scs009ltr.pdf 7/28/2003
AP07/18/2003SCS19233009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020624_S009_ANZEMET.pdf 2/19/2008
AP06/1/2005SLR11748013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020624s013ltr.pdf 6/7/2005
AP06/1/2005SLR11769013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020624s013lbl.pdf 6/7/2005
AP06/30/2007SLR16676016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s006,020624s016ltr.pdf 6/4/2007
AP06/30/2007SLR16696016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020623s006,020624s016lbl.pdf 6/4/2007
AP09/24/2007SLR18048017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020623s007, 020624s017ltr.pdf 9/26/2007
AP010/6/2009SLR23570020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020624s020lbl.pdf 10/14/2009
AP010/6/2009SLR23806020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020624s020ltr.pdf 11/10/2009
AP09/22/2011SLR30085022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020624s022ltr.pdf 9/27/2011
AP09/22/2011SLR30121022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020624s022lbl.pdf 9/29/2011
AP09/16/2013SLR37101023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020623s010lbl.pdf,020624s023lbl.pdf 9/17/2013
AP09/16/2013SLR37106023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020623Orig1s010,020624Orig1s023ltr.pdf 9/17/2013
AP09/20/2013SCM       
AP09/18/2014SLR40535025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020624s025lbl.pdf 9/22/2014
AP09/18/2014SLR40559025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020624Orig1s025ltr.pdf 9/23/2014




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