GLENMARK PHARMS LTD FDA Approval ANDA 203501

ANDA 203501

GLENMARK PHARMS LTD

FDA Drug Application

Application #203501

Application Sponsors

ANDA 203501GLENMARK PHARMS LTD

Marketing Status

Prescription001

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL75MG0INDOMETHACININDOMETHACIN

FDA Submissions

UNKNOWN; ORIG1AP2017-06-22
LABELING; LabelingSUPPL3AP2021-04-28STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7

TE Codes

001PrescriptionAB

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
        )

)

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