NDA 021231

ASTRAZENECA

FDA Drug Application

Application #021231

Documents

• Letter: 2001-02-13
• Letter: 2002-10-09
• Letter: 2003-06-08
• Letter: 2010-08-16
• Letter: 2012-09-18
• Label: 2001-02-13
• Label: 2010-08-19
• Label: 2012-09-18
• Review: 2004-06-14
• Review: 2008-02-19
• Other Important Information from FDA: 2007-01-17
• Letter: 2004-01-14
• Letter: 2012-09-18
• Label: 2012-09-18
• Label: 2018-12-26
• Letter: 2018-12-31

Application Sponsors

NDA 021231

ASTRAZENECA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	2.5MG	1	ZOMIG-ZMT	ZOLMITRIPTAN
002	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	1	ZOMIG-ZMT	ZOLMITRIPTAN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2001-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-12-04	STANDARD
LABELING; Labeling	SUPPL	3	AP	2002-10-09	STANDARD
LABELING; Labeling	SUPPL	4	AP	2003-05-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2004-01-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	2010-08-11	STANDARD
LABELING; Labeling	SUPPL	10	AP	2012-09-14	STANDARD
LABELING; Labeling	SUPPL	11	AP	2012-09-14	UNKNOWN
LABELING; Labeling	SUPPL	14	AP	2018-12-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	9	Null	6
SUPPL	10	Null	6
SUPPL	11	Null	6
SUPPL	14	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21231
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOMIG-ZMT","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZOMIG-ZMT","activeIngredients":"ZOLMITRIPTAN","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/21\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020768s023,021231s014,021450s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2012","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020768s019s021,021231s010s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2012","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020768s019s021,021231s010s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2010","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021231s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21231lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZOMIG-ZMT","submission":"ZOLMITRIPTAN","actionType":"2.5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZOMIG-ZMT","submission":"ZOLMITRIPTAN","actionType":"5MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)