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FDA Drug Application 020988 by WYETH PHARMS INC

Application Number020988
Application Type New Drug Application
Sponsor ApplicantWYETH PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/22/2001N4065000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_Approv.pdf 3/22/2001
AP03/22/2001N4066000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix_prntlbl.pdf 3/22/2001
AP03/22/2001N4067000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20988_Protonix.cfm 3/22/2001
AP03/22/2001N31075000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP01/15/2002SCM       
AP09/27/2001SCM       
AP010/19/2001SE14063003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20988s3ltr.pdf 10/19/2001
AP010/19/2001SE14064003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20988s3lbl.pdf 10/19/2001
AP07/3/2001SLR       
AP06/8/2001SCS       
AP02/21/2003SLR4273007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr007ltr.pdf 3/10/2003
AP011/28/2001SCS       
AP07/2/2002SCS       
AP01/18/2002SCS       
AP05/14/2002SCM       
AP010/28/2002SLR4068012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20987slr013,20988slr012ltr.pdf 10/28/2002
AP012/3/2002SCM       
AP012/4/2002SCS       
AP03/5/2004SLR7849015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr015ltr.pdf 3/10/2004
AP03/5/2004SLR8237015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr015_protonix_lbl.pdf 4/5/2004
AP010/24/2003SLR6877016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr016ltr.pdf 11/5/2003
AP011/18/2003SLR6990017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20988slr017ltr.pdf 11/26/2003
AP011/18/2003SLR7007017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20988slr017_protonix_lbl.pdf 12/1/2003
AP05/5/2004SLR8542019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr019ltr.pdf 5/7/2004
AP05/5/2004SLR8564019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr019_protonix_lbl.pdf 5/7/2004
AP01/9/2004SLR7517020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr020ltr.pdf 1/14/2004
AP01/9/2004SLR7556020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr020_protonix_lbl.pdf 1/15/2004
AP01/2/2004SLR7518021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr021ltr.pdf 1/14/2004
AP04/2/2004SCF8303024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988scf024ltr.pdf 4/7/2004
AP04/2/2004SCF8238024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988scf024_protonix_lbl.pdf 4/5/2004
AP04/2/2004SLR8302025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988slr025ltr.pdf 4/7/2004
AP04/2/2004SLR8236025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988slr025_protonix_lbl.pdf 4/5/2004
AP012/6/2004S10760027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s027ltr.pdf 12/8/2004
AP012/6/2004S10761027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20988s027lbl.pdf 12/8/2004
AP011/18/2004SLR10682028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s028ltr.pdf 12/2/2004
AP010/28/2004SCS10490029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20988s029ltr.pdf 10/29/2004
AP08/2/2005SLR12551031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020988s031ltr.pdf 8/8/2005
AP08/2/2005SLR12569031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s031lbl.pdf 8/8/2005
AP08/3/2005SCS12570032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020988s032lbl.pdf 8/8/2005
AP08/3/2005SCS12552032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020988s032ltr.pdf 8/8/2005
AP012/20/2007SLR18755038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020987s035,020988s038rev2_dw.pdf 1/9/2008
AP09/3/2010SLR26430040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020988s040ltr.pdf 9/8/2010
AP09/3/2010SLR26462040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020988s040lbl.pdf 9/10/2010
AP06/7/2011SLR29087041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s041ltr.pdf 6/9/2011
AP06/7/2011SLR29270041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s041lbl.pdf 6/27/2011
AP012/7/2011SLR30924042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s042ltr.pdf 12/13/2011
AP012/7/2011SLR30992042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s042lbl.pdf 12/14/2011
AP05/20/2011SLR28934043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020988s043ltr.pdf 5/25/2011
AP05/20/2011SLR28957043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020988s043lbl.pdf 5/25/2011
AP09/28/2012SLR33884044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s044lbl.pdf 10/1/2012
AP09/28/2012SLR33905044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988Orig1s044ltr.pdf 10/2/2012
AP05/10/2012SLR32683045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020988s045ltr.pdf 5/14/2012
AP05/10/2012SLR32696045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020988s045lbl.pdf 5/16/2012
AP03/4/2014SCM       
AP012/12/2013SLR38042048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020988Orig1s048ltr.pdf 12/16/2013
AP012/12/2013SLR38095048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020988s048lbl.pdf 12/17/2013
AP09/26/2014SCM       
AP09/26/2014SCM       
AP011/5/2014SCM       
AP012/19/2014SLR41366052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020988Orig1s052ltr.pdf 12/23/2014
AP012/19/2014SLR41414052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020988s052lbl.pdf 12/29/2014
AP011/9/2015SCM       
AP010/24/2016SLR47449054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/20988Orig1s054ltr.pdf 10/26/2016
AP010/24/2016SLR47529054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020988s054lbl.pdf 10/31/2016




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