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FDA Drug Application 020011 by ABBVIE ENDOCRINE INC

Application Number020011
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
AP010/22/1990N31113000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP04/26/1994SLR       
AP02/14/1994SCE       
AP011/7/1994SCS       
AP07/21/1994SLR       
AP010/26/1995SCP       
AP09/22/1995SCM       
AP08/11/1995SCS       
AP09/12/1996SLR       
AP06/27/1997SCS       
AP04/9/1998SE12743014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-s014_Lupron.cfm 8/6/2001
AP04/9/1998SE14801014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-S014_LUPRON_APPROV.PDF 4/9/1998
AP06/30/1998SCS       
AP08/13/1999SCM       
AP05/11/2000SCS       
AP05/12/2000SCS       
AP01/24/2001SCS       
AP03/1/2001SLR       
AP09/21/2001SE12747021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20011s21ltr.pdf 9/21/2001
AP09/21/2001SE12748021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20011s21lbl.pdf 9/21/2001
AP09/21/2001SE12749021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-011S021_Lupron.cfm 11/14/2001
AP011/14/2001SLR       
AP02/21/2002SCS       
AP05/23/2002SCS       
AP01/15/2004SLR7579025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf 1/22/2004
AP09/20/2002SCS       
AP01/12/2004SLR7533028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf 1/14/2004
AP09/15/2005SCS12947029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP09/15/2005SLR12948031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP010/31/2007SLR18375033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026, 020011s033, 020708s026ltr.pdf 11/8/2007
AP06/2/2009SLR22686036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf 6/4/2009
AP06/2/2009SLR22711036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019943s029,020011s036ltr.pdf 6/8/2009
AP010/29/2010SLR26836037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf 10/29/2010
AP010/29/2010SLR26852037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019943s030,020011s037ltr.pdf 11/2/2010
AP03/28/2012SLR32265038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf 3/28/2012
AP03/28/2012SLR32321038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf 4/2/2012
AP06/14/2011SLR29156039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf 6/16/2011
AP06/14/2011SLR29162039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019943s032,020011s039ltr.pdf 6/16/2011
AP01/23/2012SLR31492040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020011s040lbl.pdf 1/23/2012
AP01/23/2012SLR31511040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040ltr.pdf 1/25/2012
AP010/30/2013SLR37635041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf 10/31/2013
AP010/30/2013SLR37697041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020011s041lbl.pdf 11/5/2013




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