ANDA 070546

EUROHLTH INTL SARL

FDA Drug Application

Application #070546

Application Sponsors

ANDA 070546

EUROHLTH INTL SARL

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

BRETYLIUM TOSYLATE

BRETYLIUM TOSYLATE

FDA Submissions

	ORIG	1	AP	1986-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-01-24
LABELING; Labeling	SUPPL	4	AP	1990-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-04-03
LABELING; Labeling	SUPPL	6	AP	1994-06-22

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0

CDER Filings

EUROHLTH INTL SARL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70546
            [companyName] => EUROHLTH INTL SARL
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRETYLIUM TOSYLATE","activeIngredients":"BRETYLIUM TOSYLATE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BRETYLIUM TOSYLATE","submission":"BRETYLIUM TOSYLATE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)