Back to FDA Applications sponsored by VIVUS

FDA Drug Application 202276 by VIVUS

Application Number202276
Application Type New Drug Application
Sponsor ApplicantVIVUS
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
AP04/27/2012N32547000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276s000ltr.pdf 4/27/2012
AP04/27/2012N32551000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s000lbl.pdf 4/27/2012
AP04/27/2012N32800000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202276Orig1s000TOC.cfm 6/4/2012
AP010/31/2012SLR34273001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202276Orig1s001ltr.pdf 11/6/2012
AP010/31/2012SLR34289001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s001lbl.pdf 11/6/2012
AP08/6/2013SCM       
AP07/10/2013SCM       
AP09/17/2014SE840513005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s005ltr.pdf 9/18/2014
AP09/17/2014SE840529005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s005lbl.pdf 9/19/2014
AP04/29/2014SLR39178006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202276Orig1s006ltr.pdf 4/30/2014
AP04/29/2014SLR39210006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202276s006lbl.pdf 5/2/2014
AP011/20/2014SCM       
AP02/9/2015SCM       
AP05/13/2015SLR42831010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s010ltr.pdf 5/19/2015
AP05/13/2015SLR43002010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s010lbl.pdf 6/5/2015
AP03/3/2015SCM       
AP011/2/2015SCM       
AP09/16/2015SLR43907013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202276Orig1s013ltr.pdf 9/17/2015
AP09/16/2015SLR43967013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202276s013lbl.pdf 9/23/2015
AP06/15/2016SCM       




Back to FDA Applications sponsored by VIVUS