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FDA Drug Application 020987 by WYETH PHARMS INC

Application Number020987
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS 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
AP02/2/2000N824000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20987ltr.pdf 2/2/2000
AP02/2/2000N825000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20987lbl.pdf 2/2/2000
AP02/2/2000N4076000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20987_Protonix.cfm 2/2/2000
AP02/2/2000N31074000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP02/2/2000N34112000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM324058.pdf 10/16/2012
AP06/12/2001SE14073001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20987S1S2ltr.pdf 6/12/2001
AP06/12/2001SE15071001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/020987S1S2lbl.pdf 4/9/2003
AP06/12/2001SCF4074002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20987S1S2ltr.pdf 6/12/2001
AP010/19/2000SCM       
AP05/21/2001SLR       
AP07/20/2001SLR5488005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20987s5lbl.pdf 4/25/2003
AP06/12/2002SCM       
AP04/19/2002SE14070007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987s007.pdf 4/19/2002
AP04/19/2002SE14071007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20987s7lbl.pdf 4/19/2002
AP04/19/2002SE14072007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-987s007_Protonix.cfm 4/19/2002
AP03/12/2002SCM       
AP07/2/2002SCS       
AP05/14/2002SCM       
AP09/5/2002SCS       
AP07/22/2002SCM       
AP010/28/2002SLR4069013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987slr013,20988slr012ltr.pdf 10/28/2002
AP012/6/2002SCM       
AP012/3/2002SCS       
AP012/4/2002SCS       
AP03/5/2004SLR8240017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf 4/5/2004
AP03/5/2004SLR7850017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr017ltr.pdf 3/10/2004
AP05/5/2004SLR8536020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr020_protonix_lbl.pdf 5/7/2004
AP05/5/2004SLR8543020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr020ltr.pdf 5/7/2004
AP012/30/2003SLR7513021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20987slr021ltr.pdf 1/14/2004
AP01/9/2004SLR7516022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr022ltr.pdf 1/14/2004
AP01/9/2004SLR7555022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr022_protonix_lbl.pdf 1/15/2004
AP03/12/2004SLR7960023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987slr023ltr.pdf 3/16/2004
AP03/12/2004SLR8239023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20987slr023_protonix_lbl.pdf 4/5/2004
AP011/18/2004SLR10683026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20987s026ltr.pdf 12/2/2004
AP07/25/2006SLR14548032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020987s032LTR.pdf 7/27/2006
AP012/20/2007SLR18754035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020987s035,020988s038rev2_dw.pdf 1/9/2008
AP011/12/2009SE523896036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf 11/16/2009
AP011/12/2009SE524149036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,s037ltr.pdf 11/25/2009
AP011/12/2009SLR24150037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022020s002,020987s036,s037ltr.pdf 11/25/2009
AP011/12/2009SLR23897037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022020s002,020987s036s037lbl.pdf 11/16/2009
AP09/3/2010SLR26428038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020987s038,022020s003ltr.pdf 9/8/2010
AP09/3/2010SLR26461038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020987s038,022020s003lbl.pdf 9/10/2010
AP010/31/2011SLR30433039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022020s004,020987s039ltr.pdf 10/31/2011
AP010/31/2011SLR30454039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022020s004,020987s039lbl.pdf 11/1/2011
AP05/20/2011SLR28929041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020987s041,022020s005ltr.pdf 5/25/2011
AP05/20/2011SLR28956041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020987s041,022020s005lbl.pdf 5/25/2011
AP010/9/2012SLR34028043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020987Orig1s043,022020Orig1s006ltr.pdf 10/11/2012
AP010/9/2012SLR34106043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s043,022020s006lbl.pdf 10/15/2012
AP05/11/2012SLR32689045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020987s045lbl.pdf 5/15/2012
AP01/25/2013SCM       
AP012/10/2013SLR37998048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020987s048,022020s010lbl.pdf 12/11/2013
AP012/10/2013SLR38032048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020987Orig1s048,022020Orig1s010ltr.pdf 12/13/2013
AP012/19/2014SLR41388049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022020Orig1s011,020987Orig1s049ltr.pdf 12/24/2014
AP012/19/2014SLR41413049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf 12/29/2014
AP010/24/2016SLR47453050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020987Orig1s050,022020Orig1s012ltr.pdf 10/26/2016
AP010/24/2016SLR47531050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020987s050,022020s012lbl.pdf 10/31/2016




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