NDA 021398

ALLERGAN

FDA Drug Application

Application #021398

Documents

• Letter: 2012-10-15
• Label: 2012-10-12
• Summary Review: 2008-07-22
• Letter: 2007-11-08
• Letter: 2015-10-16
• Label: 2015-10-22
• Review: 2008-04-22
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 021398

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.2%;EQ 0.5% BASE

1

COMBIGAN

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2007-10-30	STANDARD
LABELING; Labeling	SUPPL	6	AP	2012-10-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-10-15	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	6	Null	7
SUPPL	7	Null	15

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21398
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"COMBIGAN","activeIngredients":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","strength":"0.2%;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/15\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021398s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021398s006lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COMBIGAN","submission":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","actionType":"0.2%;EQ 0.5% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-10-15
        )

)