ANDA 083342

ALCON

FDA Drug Application

Application #083342

Application Sponsors

ANDA 083342

ALCON

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;OPHTHALMIC

EQ 0.05% PHOSPHATE

0

MAXIDEX

DEXAMETHASONE SODIUM PHOSPHATE

FDA Submissions

	ORIG	1	AP	1973-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-04-12
LABELING; Labeling	SUPPL	8	AP	1989-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1991-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1993-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1992-06-05
LABELING; Labeling	SUPPL	13	AP	1993-09-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-03-23

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83342
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAXIDEX","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 0.05% PHOSPHATE","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MAXIDEX","submission":"DEXAMETHASONE SODIUM PHOSPHATE","actionType":"EQ 0.05% PHOSPHATE","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)