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FDA Drug Application 019010 by ABBVIE ENDOCRINE INC

Application Number019010
Application Type New Drug Application
Sponsor ApplicantABBVIE ENDOCRINE INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/9/1985N31110000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm209848.htm 12/20/2011
AP07/10/1986SCS       
AP01/19/1988SCS       
AP03/12/1987SLR       
AP01/14/1987SCS       
AP05/9/1988SCF17192006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019010_S006_Lupron Injection_APPROVAL PACKAGE.pdf 7/9/2007
AP010/21/1991SCS       
AP07/7/1992SCS       
AP06/9/1993SCS       
AP05/9/1994SCM       
AP05/9/1994SCS       
AP04/24/1996SCS       
AP05/28/1996SCS       
AP07/7/1997SCS       
AP07/7/1997SCS       
AP01/8/1998SCS       
AP09/25/1998SCS       
AP011/22/1999SCS       
AP012/21/2000SCS       
AP05/16/2002SCM17191023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S023_Lupron Injection_APPROVAL_PACKAGE.pdf 7/9/2007
AP05/16/2002SCM17190024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019010_S024_Lupron Injection_APPROVAL_PACKAGE.pdf 7/9/2007
AP011/25/2003SLR7023027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19010slr027ltr.pdf 12/2/2003
AP010/18/2004SLR10449028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19010s028ltr.pdf 10/22/2004
AP09/15/2005SLR12940031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf 10/20/2005
AP09/15/2005SLR17189031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019010_S031_Lupron Injection_APPROVAL_PACKAGE.pdf 7/9/2007
AP09/14/2007SLR17953032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019010s032ltr.pdf 9/25/2007
AP04/28/2010SLR25454033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019010s033,019732s031,s035,s036,020517s024,s028,s029ltr.pdf 5/4/2010
AP04/28/2010SLR25498033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019010s033,019732s031s035s036,020517s024s028s029lbl.pdf 5/7/2010
AP03/21/2011SLR28317035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s035lbl.pdf 3/21/2011
AP03/21/2011SLR28320035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019010s035ltr.pdf 3/24/2011
AP01/14/2011SLR27541036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/019010s036,019732s037,020517Orig1s031ltr_C.pdf 1/20/2011
AP01/14/2011SLR27569036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019010s036lbl.pdf 1/20/2011
AP07/10/2014SLR39844037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019010s037lbl.pdf 7/11/2014
AP07/10/2014SLR39847037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019010Orig1s037ltr.pdf 7/11/2014




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