Back to FDA Applications sponsored by BAXTER HLTHCARE

FDA Drug Application 018037 by BAXTER HLTHCARE

Application Number018037
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
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
AP02/2/1979N       
AP02/25/1980SCS       
AP06/14/1979SCS       
AP06/28/1980SCS       
AP08/2/1979SCS       
AP05/28/1980SCS       
AP08/7/1980SCS       
AP05/30/1980SCS       
AP06/18/1980SCS       
AP02/22/1980SLR       
AP04/16/1981SCS       
AP08/6/1980SCS       
AP07/31/1980SCS       
AP01/21/1981SCS       
AP05/29/1981SCS       
AP06/29/1981SCS       
AP012/21/1981SCS       
AP08/26/1981SLR       
AP04/16/1982SCS       
AP011/9/1981SCS       
AP06/3/1982SCS       
AP011/20/1981SCS       
AP07/11/1983SPD       
AP04/13/1982SLR       
AP05/25/1982SLR       
AP01/24/1985SCS       
AP03/16/1984SCS       
AP08/28/1985SCS       
AP08/28/1985SCS       
AP02/28/1984SCS       
AP010/23/1984SCS       
AP06/13/1985SCS       
AP07/3/1985SLR       
AP04/15/1985SCS       
AP02/27/1986SCP       
AP05/28/1987SCS       
AP07/25/1987SCP       
AP07/26/1989SCS       
AP02/15/1991SCS       
AP03/26/1991SCS       
AP04/29/1991SCS       
AP012/11/1991SCS       
AP09/30/1994SCS       
AP02/18/1994SCS       
AP04/29/1997SCP       
AP011/24/1999SCM       
AP04/14/2003SLR5681059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18008slr059,18037slr059,19308slr017ltr.pdf 5/29/2003
AP08/14/2001SCM       
AP06/2/2004SLR9110063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18008slr063,18037slr063,19308slr020ltr.pdf 6/7/2004
AP08/26/2005SCP12701065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/013684s092,016677s139,et al_ltr.pdf 8/31/2005
AP08/26/2005SCP12702065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/013684s092,016677s139,et al_lbl.pdf 8/31/2005
AP04/20/2007SLR16297066   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018008s066,018037s066,019308s023lbl.pdf 4/25/2007
AP04/20/2007SLR16424066   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018008s066, 018037s066, 019308s023ltr.pdf 5/1/2007
AP09/10/2013SLR37065070   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018008s070,018037s070,019308s027lbl.pdf 9/11/2013
AP09/10/2013SLR37077070   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018008Orig1s070,018037Orig1s070,019308Orig1s027ltr.pdf 9/12/2013




Back to FDA Applications sponsored by BAXTER HLTHCARE

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.