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FDA Drug Application 019943 by ABBOTT LABS

Application Number019943
Application Type New Drug Application
Sponsor ApplicantABBOTT LABS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/30/1995N17253000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019943_LupronTOC.cfm 7/9/2007
AP03/30/1995N31112000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP09/22/1995SCM       
AP012/12/1995SLR       
AP010/26/1995SCP17188003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019943_S003_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP08/11/1995SCS       
AP09/12/1996SLR       
AP06/27/1997SCS       
AP06/30/1998SCS       
AP08/13/1999SCM17187010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/019943_S010_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP05/11/2000SCS       
AP05/12/2000SCS       
AP01/24/2001SCS       
AP03/1/2001SLR       
AP011/14/2001SLR       
AP02/21/2002SCS       
AP05/23/2002SCS       
AP01/15/2004SLR7578018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf 1/22/2004
AP09/20/2002SCS       
AP01/12/2004SLR7532021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf 1/14/2004
AP09/15/2005SCS17186022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019943_S022_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP09/15/2005SCS12941022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP09/15/2005SLR12942024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP09/15/2005SLR17185024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019943_S024_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP010/31/2007SLR18374026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026, 020011s033, 020708s026ltr.pdf 11/8/2007
AP06/2/2009SLR22687029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf 6/4/2009
AP06/2/2009SLR22710029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019943s029,020011s036ltr.pdf 6/8/2009
AP010/29/2010SLR26837030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf 10/29/2010
AP010/29/2010SLR26850030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019943s030,020011s037ltr.pdf 11/2/2010
AP03/28/2012SLR32266031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf 3/28/2012
AP03/28/2012SLR32320031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf 4/2/2012
AP06/14/2011SLR29155032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf 6/16/2011
AP06/14/2011SLR29161032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019943s032,020011s039ltr.pdf 6/16/2011
AP01/23/2012SLR31493033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s033lbl.pdf 1/23/2012
AP01/23/2012SLR31510033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040ltr.pdf 1/25/2012
AP010/30/2013SLR37634034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf 10/31/2013
AP010/30/2013SLR37694034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019943s034lbl.pdf 11/5/2013




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