ANDA 086711

NEPHRON

FDA Drug Application

Application #086711

Application Sponsors

ANDA 086711

NEPHRON

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

1%

0

BETA-2

ISOETHARINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1981-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-10-27
LABELING; Labeling	SUPPL	5	AP	1997-10-27

Submissions Property Types

ORIG	1	Null	29
SUPPL	4	Null	0

CDER Filings

NEPHRON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86711
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETA-2","activeIngredients":"ISOETHARINE HYDROCHLORIDE","strength":"1%","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BETA-2","submission":"ISOETHARINE HYDROCHLORIDE","actionType":"1%","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)