ANDA 205666

AMNEAL PHARMS LLC

FDA Drug Application

Application #205666

Application Sponsors

ANDA 205666

AMNEAL PHARMS LLC

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	2018-07-19	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-07-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	9	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205666
            [companyName] => AMNEAL
            [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\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/23\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-23
        )

)