ANDA 204216

GLAND PHARMA LTD

FDA Drug Application

Application #204216

Documents

• Letter: 2016-11-03

Application Sponsors

ANDA 204216

GLAND PHARMA LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-11-01
LABELING; Labeling	SUPPL	10	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	10	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204216
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"15MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"KETOROLAC TROMETHAMINE","activeIngredients":"KETOROLAC TROMETHAMINE","strength":"30MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/01\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204216Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-01
        )

)