ANDA 078720

BIONPHARMA INC

FDA Drug Application

Application #078720

Application Sponsors

ANDA 078720

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

0

AMANTADINE HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2008-05-29
LABELING; Labeling	SUPPL	8	AP	2011-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2017-10-30

Submissions Property Types

SUPPL

13

Null

15

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78720
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMANTADINE HYDROCHLORIDE","submission":"AMANTADINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)