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FDA Drug Application 022304 by DEPOMED INC

Application Number022304
Application Type New Drug Application
Sponsor ApplicantDEPOMED INC
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
AP011/20/2008N21674000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022304s000correctedltr.pdf 1/25/2009
AP011/20/2008N21675000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_TOC.cfm 1/25/2009
AP011/20/2008N21676000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_SumR.pdf 1/25/2009
AP011/20/2008N21793000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022304s000lbl_v2.pdf 2/4/2009
AP011/9/2009SLR23911001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022304s001lbl.pdf 11/16/2009
AP011/9/2009SLR24564001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022304s001ltr.pdf 1/20/2010
AP011/1/2010SLR26847003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s003lbl.pdf 11/1/2010
AP011/1/2010SLR26888003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022304s003,s004ltr.pdf 11/4/2010
AP011/1/2010SLR26889004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022304s003,s004ltr.pdf 11/4/2010
AP011/1/2010SLR26848004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s004lbl.pdf 11/1/2010
AP07/11/2013SLR36542007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf 7/12/2013
AP07/11/2013SLR36548007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf 7/12/2013
AP07/11/2013SLR36549008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf 7/12/2013
AP07/11/2013SLR36543008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf 7/12/2013
AP07/11/2013SLR36544009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf 7/12/2013
AP07/11/2013SLR36550009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf 7/12/2013
AP07/11/2013SLR36551011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf 7/12/2013
AP07/11/2013SLR36545011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf 7/12/2013
AP07/11/2013SLR36546012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf 7/12/2013
AP07/11/2013SLR36552012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf 7/12/2013
AP01/16/2014SCM       
AP010/31/2013SLR37708014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s014,s015ltr.pdf 11/6/2013
AP010/31/2013SLR37668014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf 11/1/2013
AP010/31/2013SLR37669015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf 11/1/2013
AP010/31/2013SLR37709015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s014,s015ltr.pdf 11/6/2013




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