ANDA 080020

ALCON

FDA Drug Application

Application #080020

Application Sponsors

ANDA 080020

ALCON

Marketing Status

• Discontinued: 002

Application Products

002

SOLUTION/DROPS;OPHTHALMIC

15%

0

ISOPTO CETAMIDE

SULFACETAMIDE SODIUM

FDA Submissions

	ORIG	1	AP	1971-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1989-04-26
LABELING; Labeling	SUPPL	13	AP	1989-09-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1993-06-04
LABELING; Labeling	SUPPL	15	AP	1991-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1993-06-04
LABELING; Labeling	SUPPL	17	AP	1993-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-08-03
LABELING; Labeling	SUPPL	19	AP	1995-04-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-08-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1995-10-05
LABELING; Labeling	SUPPL	24	AP	1996-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1998-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1999-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1999-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1999-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2000-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2000-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2002-12-23

Submissions Property Types

SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80020
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOPTO CETAMIDE","activeIngredients":"SULFACETAMIDE SODIUM","strength":"15%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOPTO CETAMIDE","submission":"SULFACETAMIDE SODIUM","actionType":"15%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)