TWI PHARMS FDA Approval ANDA 211463

ANDA 211463

TWI PHARMS

FDA Drug Application

Application #211463

Application Sponsors

ANDA 211463TWI PHARMS

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONEQ 50MG BASE/VIAL0MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2019-09-13STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

TWI PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211463
            [companyName] => TWI PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MELPHALAN HYDROCHLORIDE","activeIngredients":"MELPHALAN HYDROCHLORIDE","strength":"EQ 50MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-13
        )

)

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