ANDA 065291

HIKMA PHARMS

FDA Drug Application

Application #065291

Application Sponsors

ANDA 065291

HIKMA PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	250MG	0	AMOXICILLIN	AMOXICILLIN
002	CAPSULE;ORAL	500MG	0	AMOXICILLIN	AMOXICILLIN

FDA Submissions

	ORIG	1	AP	2007-02-05
LABELING; Labeling	SUPPL	9	AP	2014-11-25

Submissions Property Types

SUPPL

9

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65291
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMOXICILLIN","activeIngredients":"AMOXICILLIN","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMOXICILLIN","activeIngredients":"AMOXICILLIN","strength":"500MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMOXICILLIN","submission":"AMOXICILLIN","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMOXICILLIN","submission":"AMOXICILLIN","actionType":"500MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)