ANDA 216715

AMNEALS PHARMS

FDA Drug Application

Application #216715

Application Sponsors

ANDA 216715

AMNEALS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

EQ 15MG BASE/5ML

0

PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE SODIUM PHOSPHATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

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
        )

)