ANDA 065225

PLIVA

FDA Drug Application

Application #065225

Application Sponsors

ANDA 065225

PLIVA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 250MG BASE

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

	ORIG	1	AP	2005-11-14
LABELING; Labeling	SUPPL	15	AP	2010-07-30
LABELING; Labeling	SUPPL	16	AP	2012-02-28
LABELING; Labeling	SUPPL	18	AP	2012-12-18	STANDARD
LABELING; Labeling	SUPPL	19	AP	2013-02-28	STANDARD
LABELING; Labeling	SUPPL	20	AP	2013-06-26	STANDARD
LABELING; Labeling	SUPPL	24	AP	2015-03-20	STANDARD
LABELING; Labeling	SUPPL	27	AP	2017-09-05	STANDARD
LABELING; Labeling	SUPPL	30	AP	2017-09-05	STANDARD
LABELING; Labeling	SUPPL	31	AP	2017-09-05	STANDARD
LABELING; Labeling	SUPPL	32	AP	2020-04-18	STANDARD
LABELING; Labeling	SUPPL	33	AP	2020-04-18	STANDARD

Submissions Property Types

SUPPL	16	Null	15
SUPPL	18	Null	15
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	24	Null	15
SUPPL	27	Null	7
SUPPL	30	Null	15
SUPPL	31	Null	15
SUPPL	32	Null	7
SUPPL	33	Null	7

TE Codes

001

Prescription

AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65225
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZITHROMYCIN","submission":"AZITHROMYCIN","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)