NDA 022427

ALLERGAN

FDA Drug Application

Application #022427

Documents

• Letter: 2009-07-30
• Letter: 2012-11-19
• Letter: 2014-12-05
• Label: 2009-08-14
• Label: 2012-11-16
• Label: 2014-12-10
• Review: 2010-01-21
• Summary Review: 2010-01-21
• Letter: 2010-07-01
• Letter: 2012-11-16
• Label: 2012-11-19

Application Sponsors

NDA 022427

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.45%

1

ACUVAIL

KETOROLAC TROMETHAMINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2009-07-22	STANDARD
LABELING; Labeling	SUPPL	3	AP	2012-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2012-11-16
LABELING; Labeling	SUPPL	5	AP	2014-12-04	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7
SUPPL	4	Null	0
SUPPL	5	Null	15

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22427
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACUVAIL","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"0.45%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/04\/2014","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022427s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2012","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022427s004lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"11\/15\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022427s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022427s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACUVAIL","submission":"KETOROLAC TROMETHAMINE","actionType":"0.45%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-12-04
        )

)