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FDA Drug Application 019962 by ASTRAZENECA PHARMS

Application Number019962
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/10/1992N       
AP02/27/1992SLR12018001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-001_Toprol_XL.pdf 7/15/2005
AP06/24/1992SLR12017002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-002_Toprol_XL.pdf 7/15/2005
AP03/4/1994SCS12016003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-003_Toprol_XL.pdf 7/15/2005
AP010/27/1994SLR12015004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-962-S-004_Toprol_XL.pdf 7/15/2005
AP02/7/1995SCS       
AP06/13/1995SCF       
AP03/12/1996SLR       
AP03/11/1996SCS       
AP06/25/1996SLR       
AP01/14/1999SCM       
AP03/5/1999SCS       
AP02/5/2001SE15187013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_Approv.pdf 7/10/2000
AP02/5/2001SE15188013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol_prntlbl.pdf 7/10/2000
AP02/5/2001SE15189013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/N-19-962S013_Toprol.cfm 7/20/2000
AP010/13/2000SCM       
AP09/28/2000SCM       
AP011/22/2000SCM       
AP02/2/2001SCM       
AP09/26/2001SCM       
AP06/12/2001SCP       
AP08/22/2001SCM       
AP010/25/2001SCP       
AP03/5/2002SLR3996022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962s22ltr.pdf 3/5/2002
AP03/5/2002SLR3997022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-962S022.pdf 5/30/2002
AP01/27/2003SLR3995024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19962slr024ltr.pdf 1/30/2003
AP02/15/2005SE211126027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s027ltr.pdf 2/17/2005
AP02/15/2005SE211136027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19962s027lbl.pdf 2/17/2005
AP04/5/2005SLR11371028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19962s028ltr.pdf 4/12/2005
AP05/4/2006SLR14060031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s031LTR.pdf 5/5/2006
AP07/27/2006SCS14577032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019962s032lbl.pdf 8/4/2006
AP07/27/2006SCS14617032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019962s032LTR.pdf 8/4/2006
AP07/18/2007SE517337033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s033ltr.pdf 7/24/2007
AP07/18/2007SE517354033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019962s033lbl.pdf 7/24/2007
AP03/14/2007SLR16069034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019962s034ltr.pdf 3/23/2007
AP02/15/2008SCS19234036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019962s036ltr.pdf 2/19/2008
AP02/15/2008SCS19266036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019962s036lbl.pdf 2/25/2008
AP02/12/2009SLR21924038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019962s038ltr.pdf 3/2/2009
AP02/12/2009SLR21925038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019962s038lbl.pdf 3/2/2009
AP03/19/2010N25094041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s041ltr.pdf 3/24/2010
AP03/19/2010N25129041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s041lbl.pdf 3/26/2010
AP01/19/2010SLR24543042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019962s042lbl.pdf 1/20/2010
AP01/19/2010SLR24642042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019962s042ltr.pdf 1/26/2010
AP010/31/2012SLR34223043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019962s43lbl.pdf 11/2/2012
AP010/31/2012SLR34250043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019962Orig1s043ltr.pdf 11/5/2012
AP05/6/2014SLR39246044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019962Orig1s044ltr.pdf 5/8/2014
AP05/6/2014SLR39282044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019962s044lbl.pdf 5/12/2014
AP05/12/2014SCM       




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