NDA 020490

ALLERGAN

FDA Drug Application

Application #020490

Documents

• Letter: 2016-03-25
• Label: 2001-12-20
• Letter: 2001-12-20
• Label: 2016-03-28
• Review: 2004-05-27

Application Sponsors

NDA 020490

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

ALPHAGAN

BRIMONIDINE TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-08-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-04-09	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2001-12-20	STANDARD
LABELING; Labeling	SUPPL	8	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	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	6
SUPPL	8	Null	7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20490
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPHAGAN","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/23\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020490s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2001","submission":"SUPPL-7","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":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2016-03-23
        )

)