NDA 020811

ALLERGAN

FDA Drug Application

Application #020811

Documents

• Letter: 2002-02-08
• Review: 1997-11-03
• Label: 2002-02-08

Application Sponsors

NDA 020811

ALLERGAN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

ACULAR PRESERVATIVE FREE

KETOROLAC TROMETHAMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-11-03	STANDARD
LABELING; Labeling	SUPPL	2	AP	2000-07-07	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2002-02-08	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20811
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACULAR PRESERVATIVE FREE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/08\/2002","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19700s019lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACULAR PRESERVATIVE FREE","submission":"KETOROLAC TROMETHAMINE","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-02-08
        )

)