ANDA 065246

PLIVA

FDA Drug Application

Application #065246

Documents

• Letter: 2006-07-13

Application Sponsors

ANDA 065246

PLIVA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

	ORIG	1	AP	2006-07-06
LABELING; Labeling	SUPPL	5	AP	2009-10-22
LABELING; Labeling	SUPPL	7	AP	2009-09-28
LABELING; Labeling	SUPPL	11	AP	2012-02-28
LABELING; Labeling	SUPPL	14	AP	2012-12-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	2013-02-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2013-07-11	STANDARD
LABELING; Labeling	SUPPL	19	AP	2017-06-28	STANDARD
LABELING; Labeling	SUPPL	22	AP	2017-06-28	STANDARD
LABELING; Labeling	SUPPL	23	AP	2017-06-28	STANDARD
LABELING; Labeling	SUPPL	24	AP	2017-06-28	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-01-13	STANDARD
LABELING; Labeling	SUPPL	26	AP	2020-01-13	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	11	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	15
SUPPL	19	Null	15
SUPPL	22	Null	7
SUPPL	23	Null	7
SUPPL	24	Null	15
SUPPL	25	Null	15
SUPPL	26	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65246
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 200MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 100MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZITHROMYCIN","submission":"AZITHROMYCIN","actionType":"EQ 200MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AZITHROMYCIN","submission":"AZITHROMYCIN","actionType":"EQ 100MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)