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FDA Drug Application 022567 by FOREST LABS LLC

Application Number022567
Application Type New Drug Application
Sponsor ApplicantFOREST LABS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/21/2011N27580000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s000MedG.pdf 1/24/2011
AP01/21/2011N27581000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s000lbl.pdf 1/24/2011
AP01/21/2011N27615000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s000ltr.pdf 1/26/2011
AP01/21/2011N27992000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000TOC.cfm 3/1/2011
AP01/21/2011N27993000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022567Orig1s000SumR.pdf 3/1/2011
AP01/21/2011N31754000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283587.htm 2/13/2012
AP01/21/2011N34827000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241524.pdf 1/3/2013
AP09/21/2011SLR30065001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s001ltr.pdf 9/23/2011
AP09/21/2011SLR30070001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s001lbl.pdf 9/23/2011
AP09/21/2011SLR30071001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022567s001MedG.pdf 9/23/2011
AP06/29/2011SLR29409002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022567s002ltr.pdf 7/6/2011
AP012/21/2012SLR34763005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022567Orig1s005ltr.pdf 12/26/2012
AP012/21/2012SLR34869005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022567s005lbl.pdf 1/11/2013
AP012/21/2012SLR34870005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022567s005mg.pdf 1/11/2013
AP012/14/2012SCM       
AP01/10/2013SCM       
AP06/8/2013SCM       
AP012/17/2013SLR38103009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022567s009lbl.pdf 12/19/2013
AP012/17/2013SLR38108009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022567Orig1s009ltr.pdf 12/19/2013
AP04/17/2014SCM       
AP04/7/2014SLR39015011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s011lbl.pdf 4/8/2014
AP04/7/2014SLR39016011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022567Orig1s011ltr.pdf 4/9/2014
AP03/16/2015SE842202012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022567s012lbl.pdf 3/19/2015
AP03/16/2015SE842378012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022567Orig1s012ltr.pdf 4/2/2015
AP07/16/2014SLR39884013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022567s013lbl.pdf 7/17/2014
AP07/16/2014SLR39889013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022567Orig1s013ltr.pdf 7/17/2014
AP06/11/2015SCM       
AP012/16/2015SCM       
AP09/2/2016SCM       
AP09/6/2016SLR46985019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022567Orig1s019ltr.pdf 9/7/2016
AP09/6/2016SLR46998019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022567s019lbl.pdf 9/8/2016




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