ANDA 204336

MACLEODS PHARMS LTD

FDA Drug Application

Application #204336

Application Sponsors

ANDA 204336

MACLEODS PHARMS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	2.5MG	0	ZOLMITRIPTAN	ZOLMITRIPTAN
002	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	0	ZOLMITRIPTAN	ZOLMITRIPTAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-10-22
LABELING; Labeling	SUPPL	10	AP	2020-03-16	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	10	Null	15

CDER Filings

MACLEODS PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204336
            [companyName] => MACLEODS PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/22\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/16\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-16
        )

)