ANDA 211147

ZYDUS

FDA Drug Application

Application #211147

Application Sponsors

ANDA 211147

ZYDUS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	EQ 100MG BASE/5ML	0	AZITHROMYCIN	AZITHROMYCIN
002	FOR SUSPENSION;ORAL	EQ 200MG BASE/5ML	0	AZITHROMYCIN	AZITHROMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-31	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-01-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

ZYDUS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211147
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 100MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 200MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/31\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/13\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-13
        )

)