NDA 019921

ALLERGAN

FDA Drug Application

Application #019921

Documents

• Review: 2006-10-26
• Label: 2016-11-16
• Letter: 2016-11-17
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01

Application Sponsors

NDA 019921

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.3%

1

OCUFLOX

OFLOXACIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1993-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1995-06-12	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1996-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-03-15	STANDARD
LABELING; Labeling	SUPPL	8	AP	1999-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-07-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-02-15	STANDARD
LABELING; Labeling	SUPPL	21	AP	2016-11-16	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	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	21	Null	7

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19921
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OCUFLOX","activeIngredients":"OFLOXACIN","strength":"0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/16\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/019921s021lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OCUFLOX","submission":"OFLOXACIN","actionType":"0.3%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-11-16
        )

)