ANDA 211068

YUNG SHIN PHARM

FDA Drug Application

Application #211068

Application Sponsors

ANDA 211068

YUNG SHIN PHARM

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-05-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-11-22	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

YUNG SHIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211068
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/08\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-08
        )

)