ANDA 213734

AMNEAL

FDA Drug Application

Application #213734

Documents

• Letter: 2020-08-24

Application Sponsors

ANDA 213734

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

METYROSINE

METYROSINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-07-24

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213734
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"METYROSINE","activeIngredients":"METYROSINE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-24
        )

)