AMNEALS PHARMS FDA Approval ANDA 216427

ANDA 216427

AMNEALS PHARMS

FDA Drug Application

Application #216427

Application Sponsors

ANDA 216427AMNEALS PHARMS

Marketing Status

Prescription001

Application Products

001FOR SUSPENSION;ORAL40MG/5ML0FAMOTIDINEFAMOTIDINE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AMNEALS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216427
            [companyName] => AMNEALS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMOTIDINE","activeIngredients":"FAMOTIDINE","strength":"40MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FAMOTIDINE","submission":"FAMOTIDINE","actionType":"40MG\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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