NDA 019404

ALLERGAN

FDA Drug Application

Application #019404

Documents

• Letter: 2004-06-10
• Letter: 2012-07-30
• Label: 2003-08-28
• Label: 2003-04-15
• Label: 2003-04-15
• Label: 2012-07-26
• Review: 2019-02-15

Application Sponsors

NDA 019404

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.03%

1

OCUFEN

FLURBIPROFEN SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1986-12-31	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1989-04-13
LABELING; Labeling	SUPPL	7	AP	1992-04-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-08-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-06-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1997-04-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-04-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-10-02	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2001-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-04-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-08-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-12-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-11-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2003-08-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-04-12	PRIORITY
LABELING; Labeling	SUPPL	26	AP	2012-07-25	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	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	26	Null	15

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19404
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OCUFEN","activeIngredients":"FLURBIPROFEN SODIUM","strength":"0.03%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/25\/2012","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019404s026lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2003","submission":"SUPPL-20","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/19404scp020_ocufen_lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2001","submission":"SUPPL-17","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19404s17lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"07\/30\/2001","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19404s14lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OCUFEN","submission":"FLURBIPROFEN SODIUM","actionType":"0.03%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-07-25
        )

)