ANDA 065218

PLIVA

FDA Drug Application

Application #065218

Application Sponsors

ANDA 065218

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 600MG BASE

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

	ORIG	1	AP	2005-11-14
LABELING; Labeling	SUPPL	13	AP	2010-07-30
LABELING; Labeling	SUPPL	15	AP	2016-11-08	STANDARD
LABELING; Labeling	SUPPL	19	AP	2020-01-08	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-01-08	STANDARD
LABELING; Labeling	SUPPL	21	AP	2020-01-08	STANDARD
LABELING; Labeling	SUPPL	22	AP	2020-01-08	STANDARD
LABELING; Labeling	SUPPL	24	AP	2021-11-22	STANDARD

Submissions Property Types

SUPPL	15	Null	15
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	15
SUPPL	22	Null	15
SUPPL	24	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65218
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZITHROMYCIN","submission":"AZITHROMYCIN","actionType":"EQ 600MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)