ANDA 078201

RUBICON

FDA Drug Application

Application #078201

Application Sponsors

ANDA 078201

RUBICON

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 2% BASE;EQ 0.5% BASE

0

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

FDA Submissions

	ORIG	1	AP	2008-10-28
LABELING; Labeling	SUPPL	4	AP	2016-04-26
LABELING; Labeling	SUPPL	5	AP	2011-02-02
LABELING; Labeling	SUPPL	12	AP	2016-04-26	STANDARD

Submissions Property Types

SUPPL	4	Null	15
SUPPL	12	Null	15

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78201
            [companyName] => RUBICON
            [docInserts] => ["",""]
            [products] => [{"drugName":"DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE","activeIngredients":"DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE","strength":"EQ 2% BASE;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE","submission":"DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE","actionType":"EQ 2% BASE;EQ 0.5% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)