ANDA 214284

ALEMBIC PHARMS LTD

FDA Drug Application

Application #214284

Application Sponsors

ANDA 214284

ALEMBIC PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

100MG

0

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-15

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ALEMBIC PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214284
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-15
        )

)