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FDA Drug Application 020622 by TEVA PHARMS USA

Application Number020622
Application Type New Drug Application
Sponsor ApplicantTEVA PHARMS USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/20/1996N       
AP011/4/1997SCS       
AP01/23/1998SCS       
AP01/23/1998SCM       
AP07/6/2000SLR       
AP02/16/1999SCM       
AP02/25/1999SCS       
AP08/9/2000SLR       
AP06/28/1999SCM       
AP07/6/2000SLR       
AP07/30/1999SCS       
AP08/3/1999SCM       
AP08/4/1999SCM       
AP08/16/1999SCM       
AP08/16/1999SCS       
AP07/12/2001SLR5493015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20622s15lbl.pdf 4/28/2003
AP07/12/2001SLR16197015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020622_S015_COPAXONE_INJECTION_AP.pdf 4/9/2007
AP09/24/1999SCM       
AP011/29/1999SCM       
AP01/25/2001SCS       
AP02/23/2001SCM       
AP02/28/2001SLR       
AP06/12/2001SLR       
AP02/12/2002SCF2564023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622s23ltr.pdf 2/12/2002
AP03/11/2002SCM       
AP05/20/2002SCM       
AP08/29/2002SLR2563026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20622slr026ltr.pdf 8/29/2002
AP02/27/2009SE121933057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020622s057ltr.pdf 3/3/2009
AP02/27/2009SE122039057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020622s057lbl.pdf 3/17/2009
AP02/22/2013SCM       
AP09/5/2013SCM       
AP09/5/2013SCM       
AP03/8/2013SCM35431087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020622s087lbl.pdf 3/12/2013
AP01/28/2014SE838397089   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020622Orig1s089ltr.pdf 1/29/2014
AP01/28/2014SE838416089   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020622s089lbl.pdf 1/31/2014
AP012/6/2013SCM       
AP01/26/2015SCM       
AP03/14/2016SCM       
AP08/3/2015SCM       
AP012/3/2015SCM       
AP010/2/2015SCM       
AP010/24/2016SCM       




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