ANDA 065191

HIKMA PHARMS

FDA Drug Application

Application #065191

Application Sponsors

ANDA 065191

HIKMA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	FOR SUSPENSION;ORAL	400MG/5ML;EQ 57MG BASE/5ML	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM
002	FOR SUSPENSION;ORAL	200MG/5ML;EQ 28.5MG BASE/5ML	0	AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM

FDA Submissions

	ORIG	1	AP	2005-01-25
LABELING; Labeling	SUPPL	6	AP	2011-01-27
LABELING; Labeling	SUPPL	7	AP	2009-08-31
LABELING; Labeling	SUPPL	9	AP	2011-01-27
LABELING; Labeling	SUPPL	13	AP	2014-11-03
LABELING; Labeling	SUPPL	14	AP	2014-11-03	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	7	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65191
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"400MG\/5ML;EQ 57MG BASE\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"200MG\/5ML;EQ 28.5MG 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":"400MG\/5ML;EQ 57MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMOXICILLIN AND CLAVULANATE POTASSIUM","submission":"AMOXICILLIN; CLAVULANATE POTASSIUM","actionType":"200MG\/5ML;EQ 28.5MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)