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FDA Drug Application 020049 by SHIRE

Application Number020049
Application Type New Drug Application
Sponsor ApplicantSHIRE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/10/1993N3757000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020049a_052292_biopharmrev.pdf 2/18/1998
AP03/11/1996SLR       
AP010/29/1997SCM       
AP02/19/1998SCP       
AP03/19/1998SCS       
AP08/5/1998SCS       
AP09/10/1999SLR3140006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20046S006_Pentasa.cfm 9/10/1999
AP09/10/1999SLR4986006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_approv.pdf 9/10/1999
AP09/10/1999SLR4987006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20049-S006_Pentasa_prntlbl.pdf 9/10/1999
AP08/24/2000SCM       
AP010/12/2000SCS       
AP09/3/2002SCM       
AP07/8/2004SCS9734015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20049scs015ltr.pdf 7/14/2004
AP07/8/2004SCS18560015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020049_S015_PENTASA.pdf 11/19/2007
AP06/27/2006SLR14413017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020049s017ltr.pdf 7/3/2006
AP06/26/2007SLR16886019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020049s019ltr.pdf 7/5/2007
AP07/23/2013SLR36610025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020049Orig1s025ltr.pdf 7/26/2013
AP07/23/2013SLR36664025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s025lbl.pdf 7/30/2013
AP012/16/2013SLR38071026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020049Orig1s026ltr.pdf 12/17/2013
AP012/16/2013SLR38080026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020049s026lbl.pdf 12/17/2013
AP08/5/2015SLR43593027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020049s027lbl.pdf 8/7/2015
AP08/5/2015SLR43605027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020049Orig1s027ltr.pdf 8/10/2015
AP08/5/2015SLR44508027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/020049Orig1s027.pdf 11/18/2015




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