Back to FDA Applications sponsored by BAYER HLTHCARE

FDA Drug Application 020375 by BAYER HLTHCARE

Application Number020375
Application Type New Drug Application
Sponsor ApplicantBAYER 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
AP012/22/1994N       
AP04/25/1995SCS6467001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S1_Climara_toc.cfm 8/8/2003
AP02/28/1995SCM6468002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S2_Climara_toc.cfm 8/8/2003
AP09/22/1995SCM6469003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S3_Climara_toc.cfm 8/8/2003
AP010/10/1995SCS6470004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S4_Climara_toc.cfm 8/8/2003
AP05/17/1996SCM6471005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020375-S5_Climara_toc.cfm 8/8/2003
AP04/11/1997SE3       
AP09/16/1997SCS6472007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020375-S7_Climara_toc.cfm 8/8/2003
AP02/27/1998SCF5638008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s8_climara.cfm 5/15/2003
AP03/23/1998SCS590009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara.cfm 3/23/1998
AP03/23/1998SCS4628009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_appltr.pdf 3/23/1998
AP03/23/1998SCS4629009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_prntlbl.pdf 3/23/1998
AP06/11/1998SCS5648010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s10_climara.cfm 5/22/2003
AP03/5/1999SLR2491011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994.cfm 3/5/1999
AP03/5/1999SLR4626011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf 3/5/1999
AP03/5/1999SLR4627011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf 3/5/1999
AP06/11/1998SCE5637012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s12_climara.cfm 5/15/2003
AP05/20/1999SLR2492013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20375-s013_climara.pdf 5/20/1999
AP04/4/2001SLR5020014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S14ltr.pdf 4/11/2001
AP04/4/2001SLR5615014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375S14lbl.pdf 4/11/2001
AP04/5/2001SE110243016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-375s016_Berlex.cfm 9/21/2004
AP04/5/2001SE15021016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S16ltr.pdf 4/5/2001
AP04/5/2001SE15454016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375s16lbl.pdf 4/24/2003
AP09/13/2002SCM       
AP012/19/2002SCM       
AP01/22/2004SLR7646020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20375slr020ltr.pdf 2/2/2004
AP01/22/2004SLR7695020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020375S020lbl.pdf 2/12/2004
AP03/18/2005SLR11279021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20375s021ltr.pdf 3/23/2005
AP06/22/2005SLR11889022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020375s022ltr.pdf 6/24/2005
AP06/22/2005SLR11890022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020375s022lbl.pdf 6/24/2005
AP012/28/2005SLR13334023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020375s023LBL.pdf 1/5/2006
AP012/28/2005SLR13351023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020375s023ltr.pdf 1/6/2006
AP03/28/2007SCS       
AP01/3/2008SLR18733026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020375s026lbl.pdf 1/8/2008
AP01/3/2008SLR18793026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020375s026ltr.pdf 1/9/2008
AP010/9/2013SLR37407027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s027ltr.pdf 10/11/2013
AP010/9/2013SLR37445027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020375s027lbl.pdf 10/17/2013
AP010/10/2013SLR37620028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s028ltr.pdf 10/31/2013
AP05/14/2013SCM       
AP08/6/2015SCM       




Back to FDA Applications sponsored by BAYER 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.