ANDA 077764

AKORN INC

FDA Drug Application

Application #077764

Documents

• Letter: 2009-03-17

Application Sponsors

ANDA 077764

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.5% BASE

0

APRACLONIDINE HYDROCHLORIDE

APRACLONIDINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-03-12
LABELING; Labeling	SUPPL	2	AP	2022-09-28	STANDARD

Submissions Property Types

SUPPL	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AT

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77764
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"APRACLONIDINE HYDROCHLORIDE","activeIngredients":"APRACLONIDINE HYDROCHLORIDE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"APRACLONIDINE HYDROCHLORIDE","submission":"APRACLONIDINE HYDROCHLORIDE","actionType":"EQ 0.5% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)