ANDA 091626

SUN PHARM INDS

FDA Drug Application

Application #091626

Application Sponsors

ANDA 091626

SUN PHARM INDS

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.05%

0

EPINASTINE HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-10-31
LABELING; Labeling	SUPPL	4	AP	2016-01-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

CDER Filings

SUN PHARM INDS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91626
            [companyName] => SUN PHARM INDS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPINASTINE HYDROCHLORIDE","activeIngredients":"EPINASTINE HYDROCHLORIDE","strength":"0.05%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EPINASTINE HYDROCHLORIDE","submission":"EPINASTINE HYDROCHLORIDE","actionType":"0.05%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)