ANDA 078395

RUBICON

FDA Drug Application

Application #078395

Documents

• Letter: 2008-11-03

Application Sponsors

ANDA 078395

RUBICON

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 2% BASE

0

DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-10-28
LABELING; Labeling	SUPPL	4	AP	2011-01-28
LABELING; Labeling	SUPPL	8	AP	2015-11-27	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-12-03	STANDARD

Submissions Property Types

SUPPL	8	Null	15
SUPPL	10	Null	15

CDER Filings

RUBICON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78395
            [companyName] => RUBICON
            [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
        )

)