NDA 021399

ASTRAZENECA

FDA Drug Application

Application #021399

Documents

• Letter: 2004-12-02
• Letter: 2005-06-21
• Label: 2004-05-07
• Label: 2005-06-17
• Review: 2003-07-15
• Letter: 2004-06-07
• Letter: 2004-05-07
• Label: 2003-05-05

Application Sponsors

NDA 021399

ASTRAZENECA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

250MG

0

IRESSA

GEFITINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2003-05-05	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2004-05-06	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2004-11-19	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2005-06-17	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21399
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRESSA","activeIngredients":"GEFITINIB","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/17\/2005","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021399s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2004","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21399slr003_Iressa_lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021399lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IRESSA","submission":"GEFITINIB","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-06-17
        )

)