ANDA 090870

BRECKENRIDGE

FDA Drug Application

Application #090870

Documents

• Letter: 2011-11-21

Application Sponsors

ANDA 090870

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.05%

0

EPINASTINE HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-03-14
LABELING; Labeling	SUPPL	6	AP	2021-01-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	15

TE Codes

001

Prescription

AT

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90870
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPINASTINE HYDROCHLORIDE","activeIngredients":"EPINASTINE HYDROCHLORIDE","strength":"0.05%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EPINASTINE HYDROCHLORIDE","submission":"EPINASTINE HYDROCHLORIDE","actionType":"0.05%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)