NDA 019216

ALLERGAN

FDA Drug Application

Application #019216

Documents

• Letter: 2006-01-20
• Label: 2006-01-13
• Letter: 2006-01-20
• Letter: 2013-02-13
• Label: 2006-01-13
• Label: 2013-02-14

Application Sponsors

NDA 019216

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.25%

1

FML FORTE

FLUOROMETHOLONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1986-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-08-28	STANDARD
LABELING; Labeling	SUPPL	3	AP	1990-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-10-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-10-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-02-27	STANDARD
LABELING; Labeling	SUPPL	7	AP	1992-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-09-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1996-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-10-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-09-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2006-01-10	STANDARD
LABELING; Labeling	SUPPL	22	AP	2006-01-10	STANDARD
LABELING; Labeling	SUPPL	25	AP	2013-02-12	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	25	Null	15

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19216
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"FML FORTE","activeIngredients":"FLUOROMETHOLONE","strength":"0.25%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/12\/2013","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019216s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2006","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019216s021s022lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2006","submission":"SUPPL-21","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019216s021s022lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FML FORTE","submission":"FLUOROMETHOLONE","actionType":"0.25%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-02-12
        )

)