ANDA 075631

BAXTER HLTHCARE CORP

FDA Drug Application

Application #075631

Application Sponsors

ANDA 075631

BAXTER HLTHCARE CORP

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	30MG/ML	0	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE
002	INJECTABLE;INJECTION	15MG/ML	0	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE

FDA Submissions

	ORIG	1	AP	2001-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-11-20
LABELING; Labeling	SUPPL	10	AP	2004-10-20
LABELING; Labeling	SUPPL	19	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	20	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	19	Null	15
SUPPL	20	Null	15

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75631
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"30MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"15MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOROLAC TROMETHAMINE","submission":"KETOROLAC TROMETHAMINE","actionType":"30MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOROLAC TROMETHAMINE","submission":"KETOROLAC TROMETHAMINE","actionType":"15MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)