ANDA 202061

EMCURE PHARMS LTD

FDA Drug Application

Application #202061

Application Sponsors

ANDA 202061

EMCURE PHARMS LTD

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

BENZPHETAMINE HYDROCHLORIDE

BENZPHETAMINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-01-27
LABELING; Labeling	SUPPL	5	AP	2021-01-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202061
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZPHETAMINE HYDROCHLORIDE","activeIngredients":"BENZPHETAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/06\/2021","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/30\/2012","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-01-06
        )

)