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FDA Drug Application 021399 by ASTRAZENECA

Application Number021399
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/5/2003N5573000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021399lbl.pdf 5/5/2003
AP05/5/2003N6125000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021399_iressa.cfm 7/15/2003
AP05/5/2003N9138000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-399_IRESSA_Approv.pdf 6/7/2004
AP05/6/2004SLR8553003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21399slr003ltr.pdf 5/7/2004
AP05/6/2004SLR8563003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21399slr003_Iressa_lbl.pdf 5/7/2004
AP011/19/2004SLR10669005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21399s005ltr.pdf 12/2/2004
AP06/17/2005SLR11831008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021399s008lbl.pdf 6/17/2005
AP06/17/2005SLR11844008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021399s008ltr.pdf 6/21/2005




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