ANDA 087771

ALCON

FDA Drug Application

Application #087771

Application Sponsors

ANDA 087771

ALCON

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;OPHTHALMIC

0.25%;10%

0

CETAPRED

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

FDA Submissions

	ORIG	1	AP	1993-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-04-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-01-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87771
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"CETAPRED","activeIngredients":"PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM","strength":"0.25%;10%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CETAPRED","submission":"PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM","actionType":"0.25%;10%","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)