ANDA 065161

SUN PHARM INDS LTD

FDA Drug Application

Application #065161

Documents

• Review: 2008-07-31

Application Sponsors

ANDA 065161

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, CHEWABLE;ORAL	200MG;EQ 28.5MG BASE	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM
002	TABLET, CHEWABLE;ORAL	400MG;EQ 57MG BASE	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM

FDA Submissions

	ORIG	1	AP	2003-12-03
LABELING; Labeling	SUPPL	2	AP	2006-03-08
LABELING; Labeling	SUPPL	4	AP	2007-10-26
LABELING; Labeling	SUPPL	8	AP	2008-05-28

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65161
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"200MG;EQ 28.5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"400MG;EQ 57MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMOXICILLIN AND CLAVULANATE POTASSIUM","submission":"AMOXICILLIN; CLAVULANATE POTASSIUM","actionType":"200MG;EQ 28.5MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMOXICILLIN AND CLAVULANATE POTASSIUM","submission":"AMOXICILLIN; CLAVULANATE POTASSIUM","actionType":"400MG;EQ 57MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)