ANDA 204730

GLENMARK PHARMS LTD

FDA Drug Application

Application #204730

Application Sponsors

ANDA 204730

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 2.5MG BASE

0

FROVATRIPTAN SUCCINATE

FROVATRIPTAN SUCCINATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-11
LABELING; Labeling	SUPPL	2	AP	2019-10-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204730
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FROVATRIPTAN SUCCINATE","activeIngredients":"FROVATRIPTAN SUCCINATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/24\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-24
        )

)