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FDA Drug Application 022580 by VIVUS

Application Number022580
Application Type New Drug Application
Sponsor ApplicantVIVUS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/17/2012N35639000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000_qsymia_toc.cfm 4/8/2013
AP07/17/2012N35640000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022580Orig1s000SumR.pdf 4/8/2013
AP07/17/2012N33212000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=45 7/18/2012
AP07/17/2012N33213000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Origs000ltr.pdf 7/18/2012
AP07/17/2012N33215000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000lbl.pdf 7/18/2012
AP07/17/2012N33216000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s000mg.pdf 7/18/2012
AP011/1/2012SLR34216001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022580s001lbl.pdf 11/2/2012
AP011/1/2012SLR34282001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022580Orig1s001ltr.pdf 11/6/2012
AP04/16/2013SLR35737004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s004lbl.pdf 4/17/2013
AP04/16/2013SLR35738004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s004mg.pdf 4/17/2013
AP04/16/2013SLR35748004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022580Orig1s004ltr.pdf 4/18/2013
AP03/19/2013SCM35541005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022580s005lbl.pdf 3/26/2013
AP010/17/2013SCM       
AP09/24/2013SCM       
AP09/26/2014S40665010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf 9/30/2014
AP09/26/2014S40649010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf 9/30/2014
AP09/26/2014SLR40650011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf 9/30/2014
AP09/26/2014SLR40666011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf 9/30/2014
AP09/26/2014SLR40667012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022580s010s011s012lbl.pdf 9/30/2014
AP09/26/2014SLR40651012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022580Orig1s010,s011,s012ltr.pdf 9/30/2014




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