Back to FDA Applications sponsored by WARNER CHILCOTT

FDA Drug Application 021823 by WARNER CHILCOTT

Application Number021823
Application Type New Drug Application
Sponsor ApplicantWARNER CHILCOTT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/12/2005N12606000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021823lbl.pdf 8/15/2005
AP08/12/2005N12633000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021823ltr.pdf 8/19/2005
AP08/12/2005N18711000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 1/7/2008
AP08/12/2005N27646000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241449.pdf 2/1/2011
AP08/12/2005N44628000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021823orig1s000.pdf 12/1/2015
AP01/24/2006SLR13482002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf 1/25/2006
AP01/24/2006SLR13543002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s019_021823s002ltr.pdf 1/30/2006
AP06/19/2006SLR14364003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s003LTR.pdf 6/28/2006
AP08/22/2006SLR14754004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021823s004_LBL.pdf 8/23/2006
AP08/22/2006SLR14895004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s004_LTR.pdf 9/18/2006
AP01/25/2011SLR27603006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf 1/26/2011
AP01/25/2011SLR27623006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf 1/27/2011
AP01/25/2011SLR27624007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf 1/27/2011
AP01/25/2011SLR27604007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf 1/26/2011
AP08/22/2011S29846008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s008ltr.pdf 8/24/2011
AP04/19/2013SLR35804009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021823s009lbl.pdf 4/23/2013
AP04/19/2013SLR35822009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021823Orig1s009ltr.pdf 4/24/2013
AP03/26/2015SLR42309010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s010ltr.pdf 3/27/2015
AP03/26/2015SLR42317010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s010lbl.pdf 3/27/2015
AP04/8/2015SLR42481011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf 4/10/2015
AP04/8/2015SLR42506011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s011ltr.pdf 4/13/2015




Back to FDA Applications sponsored by WARNER CHILCOTT

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.