NDA 019525

ALLERGAN

FDA Drug Application

Application #019525

Documents

• Letter: 2005-03-11
• Label: 2005-03-11

Application Sponsors

NDA 019525

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.1%;10%

0

FML-S

FLUOROMETHOLONE; SULFACETAMIDE SODIUM

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1989-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1990-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2005-03-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-04-12	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19525
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"FML-S","activeIngredients":"FLUOROMETHOLONE; SULFACETAMIDE SODIUM","strength":"0.1%;10%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/10\/2005","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/19525S010lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"FML-S","submission":"FLUOROMETHOLONE; SULFACETAMIDE SODIUM","actionType":"0.1%;10%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-03-10
        )

)