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FDA Drug Application 020263 by ABBVIE ENDOCRINE INC

Application Number020263
Application Type New Drug Application
Sponsor ApplicantABBVIE ENDOCRINE INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/16/1993N31114000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP01/21/1994SCS       
AP02/14/1994SCE17179003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S003_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP011/7/1994SCS       
AP03/24/1995SLR       
AP010/26/1995SCP17178006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020263_S006_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP09/22/1995SCM       
AP08/11/1995SCS       
AP01/10/1997SLR       
AP06/27/1997SCS       
AP06/30/1998SCS       
AP08/13/1999SCM17177012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020263_S012_Lupron Depot_APPROVAL_PACKAGE.pdf 7/9/2007
AP05/11/2000SCS       
AP05/12/2000SCS       
AP01/26/2001SCS       
AP08/6/2001SLR       
AP03/8/2002SCS       
AP05/16/2002SCS       
AP09/24/2002SCS2750020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20263scs020ltr.pdf 9/24/2002
AP010/28/2003SLR6853022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr022ltr.pdf 10/31/2003
AP012/23/2003SLR7416023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20263slr023ltr.pdf 12/24/2003
AP03/2/2004SLR7859024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20263slr024ltr.pdf 3/10/2004
AP03/2/2004SLR8263024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20263slr024_lupron_lbl.pdf 4/5/2004
AP011/9/2005SCS13062026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020263s026lbl.pdf 11/17/2005
AP011/9/2005SCS13082026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020263s026ltr.pdf 11/18/2005
AP02/16/2006SLR13624028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020263s028lbl.pdf 2/22/2006
AP02/16/2006SLR13647028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020263s028ltr.pdf 2/22/2006
AP02/16/2006SLR17176028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020263_S028_Lupron Depot Ped_APPROVAL PACKAGE.pdf 7/9/2007
AP07/31/2008SLR20498030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020263s030ltr.pdf 8/5/2008
AP06/24/2009SLR22839033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020263s033lbl.pdf 6/29/2009
AP06/24/2009SLR22853033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020263s033ltr.pdf 6/30/2009
AP08/30/2010SLR26344035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020263s035lbl.pdf 8/30/2010
AP08/30/2010SLR26353035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020263s035ltr.pdf 9/2/2010
AP08/15/2011SE829789036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s036lbl.pdf 8/15/2011
AP08/15/2011SE829807036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s036ltr.pdf 8/17/2011
AP010/8/2011SE830250037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020263s037ltr.pdf 10/12/2011
AP010/8/2011SE830258037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020263s037lbl.pdf 10/12/2011
AP05/14/2013SLR36077039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020263Orig1s039ltr.pdf 5/16/2013
AP05/14/2013SLR36113039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020263s039lbl.pdf 5/21/2013




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