ANDA 210001

BIONPHARMA INC

FDA Drug Application

Application #210001

Application Sponsors

ANDA 210001

BIONPHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 500MG BASE

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-02-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-07-05	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	7

TE Codes

001

Prescription

AB

CDER Filings

BIONPHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210001
            [companyName] => BIONPHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/05\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-05
        )

)