Back to FDA Applications sponsored by GILEAD SCIENCES INC

FDA Drug Application 203100 by GILEAD SCIENCES INC

Application Number203100
Application Type New Drug Application
Sponsor ApplicantGILEAD SCIENCES 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
AP08/27/2012N33572000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203100s000lbl.pdf 8/28/2012
AP08/27/2012N33579000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/0203100Orig1s000ltr.pdf 8/29/2012
AP08/27/2012N34024000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203100Orig1s000TOC.cfm 10/10/2012
AP08/27/2012N34025000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203100Orig1s000SumR.pdf 10/10/2012
AP02/15/2013SCM       
AP05/3/2013SCM       
AP010/2/2013SE837391004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s004lbl.pdf 10/8/2013
AP010/2/2013SE837392004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s004ltr.pdf 10/8/2013
AP06/19/2013SCM       
AP010/16/2013SCM       
AP011/8/2013SCM       
AP010/23/2013SLR37551009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203100Orig1s009ltr.pdf 10/25/2013
AP010/23/2013SLR37573009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203100s009lbl.pdf 10/25/2013
AP08/28/2014SE840351010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s010ltr.pdf 9/2/2014
AP08/28/2014SE840389010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s010lbl.pdf 9/3/2014
AP012/17/2014SE841297011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203100Orig1s011ltr.pdf 12/18/2014
AP012/17/2014SE841326011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203100s011lbl.pdf 12/19/2014
AP04/7/2015SCM       
AP06/8/2015SCM       
AP07/28/2015SLR43526016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203100Orig1s016ltr.pdf 7/30/2015
AP07/28/2015SLR43543016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203100s016lbl.pdf 7/30/2015
AP08/10/2015SCM       
AP02/19/2016SLR45231021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203100Orig1s021ltr.pdf 2/23/2016
AP02/19/2016SLR45240021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s021lbl.pdf 2/23/2016
AP09/2/2016SCM       
AP09/15/2016SLR47074024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203100Orig1s024ltr.pdf 9/19/2016
AP09/15/2016SLR47106024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203100s024lbl.pdf 9/20/2016




Back to FDA Applications sponsored by GILEAD SCIENCES INC

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.