NDA 021770

ALLERGAN

FDA Drug Application

Application #021770

Documents

• Letter: 2010-08-16
• Label: 2005-08-23
• Letter: 2005-08-23
• Letter: 2006-04-20
• Label: 2010-08-28
• Review: 2007-06-04

Application Sponsors

NDA 021770

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.1%

1

ALPHAGAN P

BRIMONIDINE TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2005-08-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2010-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-03-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2014-01-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2016-05-05	STANDARD

Submissions Property Types

SUPPL	4	Null	6
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0

TE Codes

001

Prescription

AB

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21770
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPHAGAN P","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/13\/2010","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021262s020,021770s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021770lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALPHAGAN P","submission":"BRIMONIDINE TARTRATE","actionType":"0.1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2010-08-13
        )

)