ANDA 204284

INVAGEN PHARMS

FDA Drug Application

Application #204284

Application Sponsors

ANDA 204284

INVAGEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	2.5MG	0	ZOLMITRIPTAN	ZOLMITRIPTAN
002	TABLET;ORAL	5MG	0	ZOLMITRIPTAN	ZOLMITRIPTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-04-09
LABELING; Labeling	SUPPL	6	AP	2020-01-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204284
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/09\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/08\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/18\/2015","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-08
        )

)