ANDA 216390

STERISCIENCE

FDA Drug Application

Application #216390

Application Sponsors

ANDA 216390

STERISCIENCE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/VIAL

0

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

STERISCIENCE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216390
            [companyName] => STERISCIENCE
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL HYDROCHLORIDE","activeIngredients":"MYCOPHENOLATE MOFETIL HYDROCHLORIDE","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-23
        )

)