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FDA Drug Application 020837 by OAK PHARMS INC

Application Number020837
Application Type New Drug Application
Sponsor ApplicantOAK PHARMS 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
AP03/25/1999N343000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20837ltr.pdf 3/25/1999
AP03/25/1999N344000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20837lbl.pdf 3/25/1999
AP03/25/1999N2016000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20837_Xenopex.cfm 3/25/1999
AP09/21/1999SCM       
AP04/12/2000SCP       
AP012/4/2000SCS       
AP02/16/2001SCE       
AP01/30/2002SE52015006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20837S6lbl.pdf 1/30/2002
AP03/4/2002SCM       
AP08/7/2002SCS       
AP07/18/2003SCS6171010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20837scs010ltr.pdf 7/28/2003
AP07/18/2003SCS15266010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020837_S010_Xopenex_APPROVAL PACKAGE.pdf 10/26/2006
AP09/7/2006SLR14840020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020837s020_ltr.pdf 9/18/2006
AP01/9/2013SCM       
AP09/7/2012SLR33692036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020837Orig1s036ltr.pdf 9/10/2012
AP09/7/2012SLR33718036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020837s036lbl.pdf 9/11/2012
AP01/9/2013SCM       
AP09/20/2013SLR37186038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020837Orig1s038ltr.pdf 9/23/2013
AP09/20/2013SLR37200038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020837s038lbl.pdf 9/24/2013
AP03/31/2014SLR38931039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020837s039lbl.pdf 4/1/2014
AP03/31/2014SLR38955039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020837Orig1s039ltr.pdf 4/2/2014
AP01/14/2014SLR38342040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020837Orig1s040ltr.pdf 1/22/2014
AP11/15/2014SLR38342040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020837Orig1s040ltr.pdf 1/22/2014
AP01/22/2015SE841672041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020837Orig1s041ltr.pdf 1/23/2015
AP01/22/2015SE841722041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s041lbl.pdf 1/29/2015
AP012/15/2014SCM       
AP03/31/2015SLR42382043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020837Orig1s043ltr.pdf 4/2/2015
AP03/31/2015SLR42525043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020837s043lbl.pdf 4/14/2015




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