ANDA 078434

AKORN

FDA Drug Application

Application #078434

Documents

• Letter: 2009-11-12

Application Sponsors

ANDA 078434

AKORN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

KETOROLAC TROMETHAMINE

KETOROLAC TROMETHAMINE

FDA Submissions

	ORIG	1	AP	2009-11-05
LABELING; Labeling	SUPPL	3	AP	2019-10-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78434
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOROLAC TROMETHAMINE","submission":"KETOROLAC TROMETHAMINE","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)