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FDA Drug Application 021450 by ASTRAZENECA

Application Number021450
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
AP09/30/2003N11430000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-450_Zomig.cfm 4/15/2005
AP09/30/2003N15678000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 1/17/2007
AP09/30/2003N6766000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21450ltr.pdf 9/30/2003
AP09/30/2003N6787000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21450_zomig_lbl.pdf 10/10/2003
AP07/2/2004SLR9713001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21450slr001ltr.pdf 7/6/2004
AP010/14/2008SE521041005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021450s005ltr.pdf 10/21/2008
AP09/16/2013SE237102007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021450s007lbl.pdf 9/16/2013
AP09/16/2013SE237134007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021450Orig1s007ltr.pdf 9/17/2013
AP06/12/2015SE843062008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021450s008lbl.pdf 6/15/2015
AP06/12/2015SE843066008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021450Orig1s008ltr.pdf 6/16/2015




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