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FDA Drug Application 020397 by ACORDA

Application Number020397
Application Type New Drug Application
Sponsor ApplicantACORDA
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
AP011/27/1996N       
AP09/2/1997SCS       
AP09/2/1997SCP       
AP010/23/1997SCM       
AP02/4/2000SCM17174004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020397_S004_ZANAFLEX TABLETS_AP.pdf 7/9/2007
AP06/15/1999SCM       
AP06/26/2000SCM       
AP08/21/2000SCM       
AP012/7/2000SCM       
AP03/20/2001SCM       
AP08/21/2001SCM       
AP08/22/2001SCM       
AP011/27/2002SLR2026014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20397slr014ltr.pdf 11/27/2002
AP04/10/2002SCE       
AP05/17/2002SCM       
AP07/28/2006SLR14581021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf 8/4/2006
AP07/28/2006SLR14607021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020397s021, 021447s002LTR.pdf 8/4/2006
AP03/19/2013SLR35484023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020397Orig1s023ltr.pdf 3/21/2013
AP05/27/2016SCM       
AP011/7/2013SLR37760026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021447Orig1s011,020397Orig1s026ltr.pdf 11/8/2013
AP011/7/2013SLR37767026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf 11/8/2013




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