ANDA 204090

EMCURE PHARMS LTD

FDA Drug Application

Application #204090

Application Sponsors

ANDA 204090

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE
002	TABLET;ORAL	EQ 10MG BASE	0	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-11-26
LABELING; Labeling	SUPPL	2	AP	2019-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204090
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/26\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/29\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/29\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-29
        )

)