NDA 019814

ALLERGAN

FDA Drug Application

Application #019814

Documents

• Label: 2003-06-10
• Label: 2003-06-10

Application Sponsors

NDA 019814

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.25%

1

BETAGAN

LEVOBUNOLOL HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-06-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	1990-01-18
LABELING; Labeling	SUPPL	3	AP	1992-02-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-06-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1997-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-10-02	STANDARD
LABELING; Labeling	SUPPL	11	AP	2001-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-04-12	STANDARD
LABELING; Labeling	SUPPL	17	AP	2003-03-19	STANDARD

Submissions Property Types

SUPPL	1	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	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19814
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAGAN","activeIngredients":"LEVOBUNOLOL HYDROCHLORIDE","strength":"0.25%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/08\/2001","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19814s12lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/14\/2001","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19814S11lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BETAGAN","submission":"LEVOBUNOLOL HYDROCHLORIDE","actionType":"0.25%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2001-08-08
        )

)