Back to FDA Applications sponsored by ABBVIE ENDOCRINE INC

FDA Drug Application 020517 by ABBVIE ENDOCRINE INC

Application Number020517
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
AP012/22/1995N13873000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020517_S000_Lupron_Depot.PDF 4/6/2006
AP012/22/1995N31115000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP012/3/1996SCP13837001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/20517S001_Lupron.pdf 3/30/2006
AP05/30/1997SE24300002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020517_s002ap.pdf 5/30/1997
AP012/23/1997SCS       
AP07/29/1998SCS       
AP08/13/1999SCM17195006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020517_S006_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP05/11/2000SCS       
AP05/12/2000SCS       
AP01/24/2001SCS       
AP03/1/2001SLR       
AP07/23/2001SCS       
AP05/23/2002SCS       
AP09/9/2003SLR6653013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20517slr013,19732slr023ltr.pdf 9/25/2003
AP09/20/2002SCS       
AP01/12/2004SLR7534016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf 1/14/2004
AP09/15/2005SCS12943018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP09/15/2005SCS17194018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020517_S018_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP09/15/2005SLR17193019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020517_S019_Lupron Depot_APPROVAL PACKAGE.pdf 7/9/2007
AP09/15/2005SLR12944019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP04/28/2010SLR25458024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf 5/4/2010
AP04/28/2010SLR25492024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf 5/7/2010
AP06/17/2011SLR41643025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf 1/20/2015
AP06/17/2011SLR29311025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf 6/28/2011
AP06/17/2011SLR29352025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf 6/29/2011
AP04/28/2010SLR25493028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf 5/7/2010
AP04/28/2010SLR25459028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf 5/4/2010
AP04/28/2010SLR25460029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf 5/4/2010
AP04/28/2010SLR25494029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf 5/7/2010
AP06/17/2011SE229353030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf 6/29/2011
AP06/17/2011SE229312030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf 6/28/2011
AP06/17/2011SE241644030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf 1/20/2015
AP01/14/2011SLR27543031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s036,019732s037,020517Orig1s031ltr_C.pdf 1/20/2011
AP01/14/2011SLR27567031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s031lbl.pdf 1/20/2011
AP06/17/2011SLR41645032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020517orig1s025s030s032Review.pdf 1/20/2015
AP06/17/2011SLR29313032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020517s025s030s032lbl.pdf 6/28/2011
AP06/17/2011SLR29354032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020517s025,s030,s032ltr.pdf 6/29/2011
AP07/18/2012SLR33237033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020517s033lbl.pdf 7/19/2012
AP07/18/2012SLR33250033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020517Origs033ltr.pdf 7/20/2012
AP011/8/2013SCM       
AP07/10/2013SLR36521035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019732s040,020517s035lbl.pdf 7/11/2013
AP07/10/2013SLR36540035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019732Orig1s040,020517Orig1s035,019732Orig1s000ltr.pdf 7/12/2013
AP06/27/2014SLR39705036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdf 7/1/2014
AP06/27/2014SLR39710036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019732Orig1s041,020517Orig1s036ltr.pdf 7/1/2014
AP02/11/2016SCM       
AP06/6/2016SLR46275038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019732Orig1s042,020517Orig1s038ltr.pdf 6/8/2016
AP06/6/2016SLR46299038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019732s042,020517s038lbl.pdf 6/13/2016




Back to FDA Applications sponsored by ABBVIE ENDOCRINE INC