ANDA 076722

GLAND PHARMA LTD

FDA Drug Application

Application #076722

Documents

• Review: 2007-07-06

Application Sponsors

ANDA 076722

GLAND PHARMA LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	15MG/ML	0	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE
002	INJECTABLE;INJECTION	30MG/ML	0	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE
003	INJECTABLE; INJECTION	60MG/2ML	0	KETOROLAC TROMETHAMINE	KETOROLAC TROMETHAMINE

FDA Submissions

	ORIG	1	AP	2004-07-27
LABELING; Labeling	SUPPL	7	AP	2016-05-09	STANDARD

Submissions Property Types

SUPPL

7

Null

15

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76722
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"15MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"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":"60MG\/2ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOROLAC TROMETHAMINE","submission":"KETOROLAC TROMETHAMINE","actionType":"15MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOROLAC TROMETHAMINE","submission":"KETOROLAC TROMETHAMINE","actionType":"30MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOROLAC TROMETHAMINE","submission":"KETOROLAC TROMETHAMINE","actionType":"60MG\/2ML","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)