ANDA 065373

HIKMA PHARMS

FDA Drug Application

Application #065373

Application Sponsors

ANDA 065373

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

FOR SUSPENSION;ORAL

600MG/5ML;EQ 42.9MG BASE/5ML

0

AMOXICILLIN AND CLAVULANATE POTASSIUM

AMOXICILLIN; CLAVULANATE POTASSIUM

FDA Submissions

	ORIG	1	AP	2007-11-09
LABELING; Labeling	SUPPL	3	AP	2013-07-31
LABELING; Labeling	SUPPL	6	AP	2014-10-26
LABELING; Labeling	SUPPL	14	AP	2020-01-27	STANDARD

Submissions Property Types

SUPPL	1	Null	7
SUPPL	3	Null	15
SUPPL	6	Null	15
SUPPL	14	Null	15

TE Codes

001

Prescription

AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65373
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN AND CLAVULANATE POTASSIUM","activeIngredients":"AMOXICILLIN; CLAVULANATE POTASSIUM","strength":"600MG\/5ML;EQ 42.9MG 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":"600MG\/5ML;EQ 42.9MG BASE\/5ML","submissionClassification":"FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)