ANDA 210043

AMNEAL

FDA Drug Application

Application #210043

Application Sponsors

ANDA 210043

AMNEAL

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	40MG/ML	0	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE
002	INJECTABLE;INJECTION	80MG/ML	0	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210043
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"80MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-20
        )

)