Back to FDA Applications sponsored by ABBVIE

FDA Drug Application 022309 by ABBVIE

Application Number022309
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
AP04/29/2011N28661000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM255313.pdf 4/29/2011
AP04/29/2011N28662000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022309s000lbl.pdf 4/29/2011
AP04/29/2011N28704000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022309s000ltr.pdf 5/5/2011
AP04/29/2011N30642000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309_androgel_toc.cfm 11/17/2011
AP04/29/2011N30643000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022309Orig1s000SumR.pdf 11/17/2011
AP04/29/2011N33720000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=5 9/12/2012
AP09/7/2012SLR33690001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022309Orig1s001ltr.pdf 9/10/2012
AP09/7/2012SLR33707001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001lbl.pdf 9/11/2012
AP09/7/2012SLR33719001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022309s001mg.pdf 9/11/2012
AP09/7/2012SLR38302001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022309Orig1s001.pdf 1/16/2014
AP011/19/2012SCM       
AP03/13/2013SCM       
AP03/12/2013SLR35451007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s007ltr.pdf 3/15/2013
AP05/20/2013SLR36119008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022309Orig1s008ltr.pdf 5/22/2013
AP05/20/2013SLR36124008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022309s008lbl.pdf 5/20/2013
AP02/28/2014SCM       
AP011/14/2014SLR41010011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s011ltr.pdf 11/18/2014
AP011/14/2014SLR41038011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s011lbl.pdf 11/20/2014
AP06/19/2014SLR39603012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022309Orig1s012ltr.pdf 6/23/2014
AP06/19/2014SLR39644012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022309s012lbl.pdf 6/23/2014
AP06/11/2015SCM       
AP05/11/2015SLR42793014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022309Orig1s014ltr.pdf 5/13/2015
AP05/11/2015SLR42806014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022309s014lbl.pdf 5/13/2015
AP08/17/2015SCM       
AP010/25/2016SLR47480017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022309Orig1s017ltr.pdf 10/27/2016
AP010/25/2016SLR47543017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022309s017lbl.pdf 11/2/2016




Back to FDA Applications sponsored by ABBVIE