AMNEALS PHARMS FDA Approval ANDA 216715

ANDA 216715

AMNEALS PHARMS

FDA Drug Application

Application #216715

Application Sponsors

ANDA 216715AMNEALS PHARMS

Marketing Status

Prescription001

Application Products

001SOLUTION;ORALEQ 15MG BASE/5ML0PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

AMNEALS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216715
            [companyName] => AMNEALS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE","strength":"EQ 15MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-25
        )

)

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