NDA 019219

ALLERGAN

FDA Drug Application

Application #019219

Documents

• Label: 2003-04-15
• Letter: 2017-12-27
• Label: 2017-12-27
• Review: 2019-02-15

Application Sponsors

NDA 019219

ALLERGAN

Marketing Status

• Prescription: 002

Application Products

002

SOLUTION/DROPS;OPHTHALMIC

0.5%

1

BETAGAN

LEVOBUNOLOL HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1985-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-09-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	1987-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-10-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	1988-11-09
LABELING; Labeling	SUPPL	7	AP	1989-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-12-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	1990-01-31
LABELING; Labeling	SUPPL	11	AP	1992-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1995-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-10-02	STANDARD
LABELING; Labeling	SUPPL	19	AP	2001-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2001-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2015-12-16	STANDARD
LABELING; Labeling	SUPPL	29	AP	2017-12-22	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	9	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	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	15

TE Codes

002

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19219
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAGAN","activeIngredients":"LEVOBUNOLOL HYDROCHLORIDE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/22\/2017","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/019219s029lbl.pdf\"}]","notes":""},{"actionDate":"08\/08\/2001","submission":"SUPPL-20","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19219s20lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"BETAGAN","submission":"LEVOBUNOLOL HYDROCHLORIDE","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-22
        )

)