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FDA Drug Application 018117 by ABBVIE

Application Number018117
Application Type New Drug Application
Sponsor ApplicantABBVIE
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
AP04/23/1982N       
AP03/12/1984SCM       
AP03/12/1984SLR       
AP03/13/1984SCS       
AP03/13/1984SCM       
AP07/31/1984SLR       
AP011/26/1984SCS       
AP09/30/1985SCM       
AP07/23/1987SCS       
AP07/3/1989SCP       
AP07/13/1989SCS       
AP05/15/1990SCM       
AP011/1/1990SCS       
AP05/16/1990SCS       
AP02/12/1992SCS       
AP05/17/1991SCM       
AP02/18/1992SCM       
AP09/27/1990SCS       
AP011/30/1992SCM       
AP011/21/1996SCM       
AP010/30/1996SE2       
AP07/2/1996SCP       
AP06/12/1997SCP       
AP02/8/1999SLR8790029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18117s029_azmacort_approv_prntlbl_medr_admindocs_corres.pdf 5/27/2004
AP04/13/2007SLR16246030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018117s030ltr.pdf 4/20/2007
AP04/13/2007SLR16274030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018117s030lbl.pdf 4/20/2007
AP08/17/2000SCS       
AP09/4/2003SLR6647032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18117slr032ltr.pdf 9/25/2003
AP09/4/2003SLR6676032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr032_azmacort_lbl.pdf 9/25/2003
AP012/18/2003SLR7344033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18117slr033ltr.pdf 12/23/2003
AP012/18/2003SLR7426033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr033_azmacort_lbl.pdf 12/29/2003
AP012/23/2003SLR7491034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18117slr034ltr.pdf 1/9/2004
AP012/23/2003SLR7545034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/18117slr034_azmacort_lbl.pdf 1/15/2004
AP09/5/2006SCP14849037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018117s037_ltr.pdf 9/18/2006
AP03/13/2008SLR19468042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018117s042ltr.pdf 3/17/2008
AP03/13/2008SLR19473042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018117s042lbl.pdf 3/17/2008




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