NDA 020613

ALLERGAN

FDA Drug Application

Application #020613

Documents

• Letter: 2001-12-20
• Letter: 2016-03-25
• Label: 2016-03-29
• Label: 2001-12-20
• Review: 2004-05-27
• Review: 2019-02-15

Application Sponsors

NDA 020613

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

ALPHAGAN

BRIMONIDINE TARTRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-05-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	1999-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-08-26	STANDARD
LABELING; Labeling	SUPPL	8	AP	1999-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-10-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-12-04	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2001-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-04-12	STANDARD
LABELING; Labeling	SUPPL	24	AP	2003-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2013-06-06	STANDARD
LABELING; Labeling	SUPPL	31	AP	2016-03-23	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	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	6
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	15

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20613
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPHAGAN","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/23\/2016","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020613s031lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2001","submission":"SUPPL-18","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21262s6lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALPHAGAN","submission":"BRIMONIDINE TARTRATE","actionType":"0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-03-23
        )

)