Documents
Application Sponsors
Marketing Status
| Prescription | 003 |
| Prescription | 004 |
Application Products
| 003 | SPRAY;NASAL | 2.5MG/SPRAY | 1 | ZOMIG | ZOLMITRIPTAN |
| 004 | SPRAY;NASAL | 5MG/SPRAY | 1 | ZOMIG | ZOLMITRIPTAN |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2003-09-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2008-10-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2013-09-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2015-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2018-12-21 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 10 | Null | 7 |
TE Codes
| 003 | Prescription | AB |
| 004 | Prescription | AB |
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 21450
[companyName] => ASTRAZENECA
[docInserts] => ["",""]
[products] => [{"drugName":"ZOMIG","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZOMIG","activeIngredients":"ZOLMITRIPTAN","strength":"5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/21\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020768s023,021231s014,021450s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2015","submission":"SUPPL-8","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021450s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/16\/2013","submission":"SUPPL-7","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021450s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21450_zomig_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ZOMIG","submission":"ZOLMITRIPTAN","actionType":"2.5MG\/SPRAY","submissionClassification":"SPRAY;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZOMIG","submission":"ZOLMITRIPTAN","actionType":"5MG\/SPRAY","submissionClassification":"SPRAY;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-12-21
)
)