ALEMBIC PHARMS LTD FDA Approval ANDA 216967

ANDA 216967

ALEMBIC PHARMS LTD

FDA Drug Application

Application #216967

Application Sponsors

ANDA 216967ALEMBIC PHARMS LTD

Marketing Status

Prescription001

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL375MG0MESALAMINEMESALAMINE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-28STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216967
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"375MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/28\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-28
        )

)

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