ANDA 200899

BIONPHARMA INC

FDA Drug Application

Application #200899

Application Sponsors

ANDA 200899

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

0.5MG

0

DUTASTERIDE

DUTASTERIDE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2015-11-20
LABELING; Labeling	SUPPL	2	AP	2020-09-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200899
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUTASTERIDE","activeIngredients":"DUTASTERIDE","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-20
        )

)