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FDA Drug Application 020708 by ABBVIE ENDOCRINE INC

Application Number020708
Application Type New Drug Application
Sponsor ApplicantABBVIE ENDOCRINE 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
AP03/7/1997N6450000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020708_lupron_toc.cfm 8/8/2003
AP03/7/1997N31116000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP09/4/1997SLR       
AP012/23/1997SCS       
AP04/9/1998SLR4802003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-S014_LUPRON_APPROV.PDF 4/9/1998
AP04/9/1998SLR2744003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-s014_Lupron.cfm 8/6/2001
AP07/29/1998SCS       
AP02/11/1999SE8855005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5.cfm 6/22/1999
AP02/11/1999SE84803005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20708s5_appltr.pdf 2/11/1999
AP08/13/1999SCM17202006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020708_S006_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP05/11/2000SCS       
AP05/12/2000SCS       
AP01/24/2001SCS       
AP03/1/2001SLR       
AP09/21/2001SE12745011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20708s11ltr.pdf 9/21/2001
AP09/21/2001SE12746011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron.cfm 11/14/2001
AP09/21/2001SE14800011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-708S011_Lupron_prntlbl.pdf 9/21/2001
AP07/23/2001SCS       
AP011/14/2001SLR       
AP05/23/2002SCS       
AP01/15/2004SLR7580015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf 1/22/2004
AP09/20/2002SCS       
AP01/12/2004SLR7535018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf 1/14/2004
AP09/15/2005SCS12945020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP09/15/2005SCS17201020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020708_S020_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP09/15/2005SLR12946021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP09/15/2005SLR17200021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020708_S021_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP010/31/2007SLR18376026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026, 020011s033, 020708s026ltr.pdf 11/8/2007
AP06/2/2009SLR22688029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020708s029lbl.pdf 6/4/2009
AP06/2/2009SLR22715029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020708s029ltr.pdf 6/8/2009
AP010/29/2010SLR26838030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020708s030lbl.pdf 10/29/2010
AP010/29/2010SLR26851030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020708s030ltr.pdf 11/2/2010
AP03/28/2012SLR32264031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf 3/28/2012
AP03/28/2012SLR32319031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf 4/2/2012
AP06/14/2011SLR29164032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020708s032ltr.pdf 6/16/2011
AP06/14/2011SLR29180032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020708s032lbl.pdf 6/16/2011
AP01/23/2012SLR31491033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020708s033lbl.pdf 1/23/2012
AP01/23/2012SLR31513033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s033ltr.pdf 1/25/2012
AP010/30/2013SLR37633034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf 10/31/2013
AP010/30/2013SLR37698034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020708s034lbl.pdf 11/5/2013




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