NDA 021262

ALLERGAN

FDA Drug Application

Application #021262

Documents

• Letter: 2004-02-27
• Label: 2001-12-20
• Label: 2006-05-24
• Label: 2010-08-28
• Letter: 2001-03-16
• Letter: 2001-12-20
• Letter: 2004-02-27
• Letter: 2006-05-25
• Letter: 2010-08-16
• Label: 2001-03-16
• Review: 2004-05-27
• Review: 2004-05-27

Application Sponsors

NDA 021262

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.15%

1

ALPHAGAN P

BRIMONIDINE TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2001-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-10-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-12-04	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2001-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-01-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-04-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2004-02-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2004-02-10	STANDARD
LABELING; Labeling	SUPPL	18	AP	2006-05-22	STANDARD
LABELING; Labeling	SUPPL	20	AP	2010-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2014-05-19	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	6
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	20	Null	6
SUPPL	24	Null	0

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21262
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPHAGAN P","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.15%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/13\/2010","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021262s020,021770s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2006","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021262s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2001","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21262s6lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALPHAGAN P","submission":"BRIMONIDINE TARTRATE","actionType":"0.15%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2010-08-13
        )

)