ANDA 214178

INVATECH

FDA Drug Application

Application #214178

Application Sponsors

ANDA 214178

INVATECH

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

50MG/5ML

0

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-08-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

INVATECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214178
            [companyName] => INVATECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"50MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-20
        )

)