Back to FDA Applications sponsored by ACS DOBFAR INFO SA

FDA Drug Application 203231 by ACS DOBFAR INFO SA

Application Number203231
Application Type New Drug Application
Sponsor ApplicantACS DOBFAR INFO SA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA011/9/2012TA34369000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203231Orig1s000TAltr.pdf 11/13/2012
AP18/2/2013N34369000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203231Orig1s000TAltr.pdf 11/13/2012
TA011/9/2012TA36689000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203231Orig1s000ltr.pdf 8/5/2013
AP18/2/2013N36689000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203231Orig1s000ltr.pdf 8/5/2013
TA011/9/2012TA36707000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203231s000lbl.pdf 8/6/2013
AP18/2/2013N36707000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203231s000lbl.pdf 8/6/2013
TA011/9/2012TA39090000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203231Orig1s000TOC.cfm 4/17/2014
AP18/2/2013N39090000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203231Orig1s000TOC.cfm 4/17/2014
AP02/7/2014SCM       
AP05/2/2014SLR39213002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s002ltr.pdf 5/6/2014
AP05/2/2014SLR39237002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s002lbl.pdf 5/6/2014
AP03/11/2014SCM       
AP012/10/2014SLR41226005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf 12/12/2014
AP012/10/2014SLR41221005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf 12/11/2014
AP012/10/2014SLR41222006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf 12/11/2014
AP012/10/2014SLR41227006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf 12/12/2014
AP012/10/2014SLR41228007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203231Orig1s005,s006,s007ltr.pdf 12/12/2014
AP012/10/2014SLR41223007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203231s005s006s007lbl.pdf 12/11/2014
AP08/31/2015SCM       
AP08/31/2015SCM       
AP010/8/2015SLR44193010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203231Orig1s010ltr.pdf 10/13/2015
AP010/8/2015SLR44207010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203231s010lbl.pdf 10/15/2015
AP03/25/2016SLR45526011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203231s011lbl.pdf 3/29/2016
AP03/25/2016SLR45533011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203231Orig1s011ltr.pdf 3/29/2016




Back to FDA Applications sponsored by ACS DOBFAR INFO SA

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.