ANDA 203501

GLENMARK PHARMS LTD

FDA Drug Application

Application #203501

Application Sponsors

ANDA 203501

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

75MG

0

INDOMETHACIN

INDOMETHACIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-06-22
LABELING; Labeling	SUPPL	3	AP	2021-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203501
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDOMETHACIN","activeIngredients":"INDOMETHACIN","strength":"75MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/16\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-16
        )

)