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FDA Drug Application 206619 by ABBVIE INC

Application Number206619
Application Type New Drug Application
Sponsor ApplicantABBVIE INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/19/2014N41354000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206619lbl.pdf 12/23/2014
AP012/19/2014N41373000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206619Orig1s000ltr.pdf 12/23/2014
AP012/19/2014N41673000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206619Orig1s000TOC.cfm 1/23/2015
AP012/19/2014N41674000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206619Orig1s000SumR.pdf 1/23/2015
AP06/19/2015SCM       
AP07/9/2015SLR       
AP03/25/2015SLR42292003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s003ltr.pdf 3/26/2015
AP03/25/2015SLR42297003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s003lbl.pdf 3/26/2015
AP07/30/2015SCM       
AP07/20/2015SLR43430005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s005ltr.pdf 7/22/2015
AP07/20/2015SLR43447005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s005lbl.pdf 7/22/2015
AP010/13/2015SLR44204006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s006ltr.pdf 10/14/2015
AP010/13/2015SLR44210006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s006lbl.pdf 10/15/2015
AP09/22/2015SCM       
AP010/22/2015SLR44273008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s008lbl.pdf 10/23/2015
AP010/22/2015SLR44282008   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467825.pdf 10/23/2015
AP010/22/2015SLR44299008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206619Orig1s008ltr.pdf 10/26/2015
AP04/22/2016SE845742009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s009ltr.pdf 4/26/2016
AP04/22/2016SE845771009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619s009lbl.pdf 4/27/2016
AP01/28/2016SLR45049010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s010ltr.pdf 1/29/2016
AP01/28/2016SLR45065010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619s010lbl.pdf 2/1/2016
AP06/21/2016SLR46403011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206619Orig1s011ltr.pdf 6/23/2016
AP06/21/2016SLR46409011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206619Orig1s011lbl.pdf 6/23/2016
AP08/17/2016SCM47285012   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM524188.pdf 10/5/2016




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