ANDA 079186

AM REGENT

FDA Drug Application

Application #079186

Application Sponsors

ANDA 079186

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 2% BASE

0

DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2009-11-18
LABELING; Labeling	SUPPL	3	AP	2020-03-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79186
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE","strength":"EQ 2% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DORZOLAMIDE HYDROCHLORIDE","submission":"DORZOLAMIDE HYDROCHLORIDE","actionType":"EQ 2% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)