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FDA Drug Application 200533 by DEPOMED INC

Application Number200533
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
AP08/25/2011N29899000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200533s000lbl.pdf 8/26/2011
AP08/25/2011N29909000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200533s000ltr.pdf 8/29/2011
AP08/25/2011N29918000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 8/30/2011
AP08/25/2011N29939000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM270268.pdf 9/2/2011
AP08/25/2011N32403000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200533Orig1s000TOC.cfm 4/12/2012
AP08/28/2012SE133585001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s001ltr.pdf 8/29/2012
AP08/28/2012SE133587001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s001lbl.pdf 8/29/2012
AP08/28/2012SE133588001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s001mg.pdf 8/29/2012
AP07/9/2012SLR33144002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s002ltr.pdf 7/11/2012
AP07/9/2012SLR33159002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s002lbl.pdf 7/12/2012
AP04/15/2013SLR35744004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200533Orig1s004ltr.pdf 4/18/2013
AP01/16/2014SCM       
AP04/16/2014SLR39059010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200533s010lbl.pdf 4/16/2014
AP04/16/2014SLR39079010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200533Orig1s010ltr.pdf 4/17/2014
AP08/19/2014S40277011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200533Orig1s011ltr.pdf 8/20/2014
AP06/26/2015S43262012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200533Orig1s012ltr.pdf 7/7/2015
AP04/20/2016S45724013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s013ltr.pdf 4/22/2016
AP09/30/2016S47260015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s015ltr.pdf 10/3/2016




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