ANDA 077259

FDC LTD

FDA Drug Application

Application #077259

Application Sponsors

ANDA 077259

FDC LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION/DROPS;OPHTHALMIC	EQ 0.25% BASE	0	TIMOLOL MALEATE	TIMOLOL MALEATE
002	SOLUTION/DROPS;OPHTHALMIC	EQ 0.5% BASE	0	TIMOLOL MALEATE	TIMOLOL MALEATE

FDA Submissions

	ORIG	1	AP	2008-04-30
LABELING; Labeling	SUPPL	4	AP	2010-03-25

Submissions Property Types

SUPPL

4

Null

7

TE Codes

001	Prescription	AT
002	Prescription	AT1

CDER Filings

FDC LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77259
            [companyName] => FDC LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.25% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIMOLOL MALEATE","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TIMOLOL MALEATE","submission":"TIMOLOL MALEATE","actionType":"EQ 0.25% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"TIMOLOL MALEATE","submission":"TIMOLOL MALEATE","actionType":"EQ 0.5% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)