LONG GROVE PHARMS FDA Approval ANDA 214499

ANDA 214499

LONG GROVE PHARMS

FDA Drug Application

Application #214499

Application Sponsors

ANDA 214499LONG GROVE PHARMS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 0.25MG BASE/ML0CARBOPROST TROMETHAMINECARBOPROST TROMETHAMINE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-09STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

LONG GROVE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214499
            [companyName] => LONG GROVE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBOPROST TROMETHAMINE","activeIngredients":"CARBOPROST TROMETHAMINE","strength":"EQ 0.25MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-09
        )

)

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