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FDA Drug Application 019732 by ABBVIE ENDOCRINE INC

Application Number019732
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/26/1989N31111000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP012/14/1990SCS       
AP03/26/1992SCM       
AP04/26/1994SLR       
AP02/14/1994SCE15261007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019732_S007_Lupron Depot_APPROVAL PACKAGE.pdf 10/26/2006
AP011/8/1994SCS       
AP010/26/1995SCP15262009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019732_S009_Lupron Depot_APPROVAL PACKAGE.pdf 10/26/2006
AP09/22/1995SCM       
AP08/11/1995SCS       
AP01/9/1998SLR5779012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019732s012_lupron.cfm 5/30/2003
AP01/9/1998SLR5780012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON%20DEPOT_APPROV.PDF 5/30/2003
AP01/9/1998SLR5781012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19732-S012_LUPRON%20DEPOT_PRNTLBL.PDF 5/30/2003
AP06/27/1997SCS       
AP06/30/1998SCS       
AP010/4/1999SLR       
AP08/13/1999SCM15263016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019732_S016_Lupron Depot_APPROVAL PACKAGE.pdf 10/26/2006
AP05/11/2000SCS       
AP05/12/2000SCS       
AP01/24/2001SCS       
AP03/1/2001SLR       
AP02/21/2002SCS       
AP05/23/2002SCS       
AP09/9/2003SLR6655023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20517slr013,19732slr023ltr.pdf 9/25/2003
AP09/20/2002SCS       
AP01/12/2004SLR7531026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf 1/14/2004
AP09/15/2005SCS12938027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP09/15/2005SCS15264027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019732_S027_Lupron Depot_APPROVAL PACKAGE.pdf 10/26/2006
AP09/15/2005SLR12939029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP09/15/2005SLR15265029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019732_S029_Lupron Depot_APPROVAL PACKAGE.pdf 10/26/2006
AP04/28/2010SLR25455031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf 5/4/2010
AP04/28/2010SLR25495031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf 5/7/2010
AP04/28/2010SLR25456035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf 5/4/2010
AP04/28/2010SLR25496035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf 5/7/2010
AP04/28/2010SLR25457036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf 5/4/2010
AP04/28/2010SLR25497036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf 5/7/2010
AP01/14/2011SLR27542037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,020517Orig1s031ltr_C.pdf 1/20/2011
AP01/14/2011SLR27568037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019732s037lbl.pdf 1/20/2011
AP02/17/2012SLR31844038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019732s038lbl.pdf 2/22/2012
AP02/17/2012SLR31867038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019732s038ltr.pdf 2/23/2012
AP07/10/2013SLR36522040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf 7/11/2013
AP07/10/2013SLR36539040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019732Orig1s040,020517Orig1s035,019732Orig1s000ltr.pdf 7/12/2013
AP06/27/2014SLR39706041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf 7/1/2014
AP06/27/2014SLR39709041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019732Orig1s041,020517Orig1s036ltr.pdf 7/1/2014
AP06/6/2016SLR46274042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019732Orig1s042,020517Orig1s038ltr.pdf 6/8/2016
AP06/6/2016SLR46300042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf 6/13/2016




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