ANDA 065431

WOCKHARDT BIO AG

FDA Drug Application

Application #065431

Documents

• Letter: 2008-11-28

Application Sponsors

ANDA 065431

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

250MG/5ML;EQ 62.5MG BASE/5ML

0

AMOXICILLIN AND CLAVULANATE POTASSIUM

AMOXICILLIN; CLAVULANATE POTASSIUM

FDA Submissions

	ORIG	1	AP	2008-11-25
LABELING; Labeling	SUPPL	7	AP	2016-05-12	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	7	Null	15

TE Codes

001

Prescription

AB

CDER Filings

WOCKHARDT BIO AG

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65431
            [companyName] => WOCKHARDT BIO AG
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"250MG\/5ML;EQ 62.5MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMOXICILLIN AND CLAVULANATE POTASSIUM","submission":"AMOXICILLIN; CLAVULANATE POTASSIUM","actionType":"250MG\/5ML;EQ 62.5MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)