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FDA Drug Application 022569 by DEPOMED INC

Application Number022569
Application Type New Drug Application
Sponsor ApplicantDEPOMED INC
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
AP06/30/2011N29413000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s000ltr.pdf 7/6/2011
AP06/30/2011N29427000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022569s000lbl.pdf 7/6/2011
AP06/30/2011N29464000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=60 7/8/2011
AP06/30/2011N29515000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM263032.pdf 7/15/2011
AP06/30/2011N32433000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022569Orig1s000TOC.cfm 4/16/2012
AP06/30/2011N32434000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022569Orig1s000SumR.pdf 4/16/2012
AP011/4/2011SLR30569002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s002ltr.pdf 11/14/2011
AP012/28/2011SLR31300005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022569s005lbl.pdf 12/28/2011
AP012/28/2011SLR31327005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022569s005ltr.pdf 1/3/2012
AP06/5/2012SLR32853007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022569s007ltr.pdf 6/7/2012
AP06/5/2012SLR32884007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022569s007lbl.pdf 6/11/2012
AP011/7/2013SCM37797012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s017ltr.pdf 11/13/2013
AP011/7/2013SCM37853012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf 11/19/2013
AP012/24/2014SLR41555013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf 1/8/2015
AP012/24/2014SLR41467013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569Orig1s019,022569Orig1s020ltr.pdf 12/31/2014
AP011/7/2013SE837796015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s017ltr.pdf 11/13/2013
AP011/7/2013SE837854015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf 11/19/2013
AP08/11/2015SCM       
AP011/7/2013SCP37855017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022569Orig1s012,s015,s017lbl.pdf 11/19/2013
AP011/7/2013SCP37795017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022569Orig1s012,s015,s017ltr.pdf 11/13/2013
AP04/7/2014SCM       
AP012/24/2014SLR41468019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569Orig1s019,022569Orig1s020ltr.pdf 12/31/2014
AP012/24/2014SLR41556019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf 1/8/2015
AP012/24/2014S41563020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022569s013s019s020lbl.pdf 1/9/2015
AP012/24/2014S41469020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022569Orig1s013,022569Orig1s019,022569Orig1s020ltr.pdf 12/31/2014
AP09/30/2014SCM       
AP012/21/2015SCM44844022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022569Orig1s022ltr.pdf 12/22/2015




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