ANDA 212182

BIONPHARMA INC

FDA Drug Application

Application #212182

Application Sponsors

ANDA 212182

BIONPHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	150MG	0	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE
002	CAPSULE, EXTENDED RELEASE;ORAL	100MG	0	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2020-02-14

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212182
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUVOXAMINE MALEATE","activeIngredients":"FLUVOXAMINE MALEATE","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/11\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-11
        )

)