ANDA 214580

HUMANWELL PURACAP

FDA Drug Application

Application #214580

Application Sponsors

ANDA 214580

HUMANWELL PURACAP

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

0

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-12-20

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

HUMANWELL PURACAP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214580
            [companyName] => HUMANWELL PURACAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMANTADINE HYDROCHLORIDE","submission":"AMANTADINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)