ANDA 075284

PLIVA

FDA Drug Application

Application #075284

Documents

• Letter: 1999-06-23
• Review: 2005-07-22

Application Sponsors

ANDA 075284

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

KETOROLAC TROMETHAMINE

KETOROLAC TROMETHAMINE

FDA Submissions

	ORIG	1	AP	1999-06-23
LABELING; Labeling	SUPPL	5	AP	2005-04-12
LABELING; Labeling	SUPPL	6	AP	2007-02-06
LABELING; Labeling	SUPPL	11	AP	2016-05-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	11	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75284
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOROLAC TROMETHAMINE","submission":"KETOROLAC TROMETHAMINE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)