NDA 021528

ALLERGAN

FDA Drug Application

Application #021528

Documents

• Letter: 2003-06-08
• Letter: 2008-12-04
• Label: 2003-06-08
• Label: 2016-06-01
• Review: 2003-11-06
• Letter: 2021-03-09
• Label: 2021-03-09

Application Sponsors

NDA 021528

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.4%

1

ACULAR LS

KETOROLAC TROMETHAMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2003-05-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2008-12-01	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-05-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-03-05	STANDARD

Submissions Property Types

SUPPL	7	Null	6
SUPPL	8	Null	6

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21528
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACULAR LS","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"0.4%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/25\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021528s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21528_acular_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACULAR LS","submission":"KETOROLAC TROMETHAMINE","actionType":"0.4%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-05-25
        )

)