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FDA Drug Application 021231 by ASTRAZENECA

Application Number021231
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
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
AP02/13/2001N1482000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21231ltr.pdf 2/13/2001
AP02/13/2001N1483000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21231lbl.pdf 2/13/2001
AP02/13/2001N9360000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-231_Zomig.cfm 6/14/2004
AP02/13/2001N15677000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 1/17/2007
AP09/17/2001SCM       
AP012/4/2001SCM       
AP010/9/2002SLR19193003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021231_S003_ZOMIG_TABLETS.pdf 2/19/2008
AP010/9/2002SLR2184003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768slr010,21231slr003ltr.pdf 10/9/2002
AP05/21/2003SLR5828004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr004ltr.pdf 6/8/2003
AP01/8/2004SLR7528005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf 1/14/2004
AP08/11/2010SLR26219009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021231s009ltr.pdf 8/16/2010
AP08/11/2010SLR26255009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021231s009lbl.pdf 8/19/2010
AP09/14/2012SLR33779010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf 9/18/2012
AP09/14/2012SLR33787010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf 9/18/2012
AP09/14/2012SLR33788011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf 9/18/2012
AP09/14/2012SLR33780011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf 9/18/2012




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