ALEMBIC PHARMS LTD FDA Approval ANDA 213251

ANDA 213251

ALEMBIC PHARMS LTD

FDA Drug Application

Application #213251

Application Sponsors

ANDA 213251ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2.5MG0METOLAZONEMETOLAZONE
002TABLET;ORAL5MG0METOLAZONEMETOLAZONE
003TABLET;ORAL10MG0METOLAZONEMETOLAZONE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-02STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213251
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOLAZONE","activeIngredients":"METOLAZONE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOLAZONE","activeIngredients":"METOLAZONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOLAZONE","activeIngredients":"METOLAZONE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-02
        )

)

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