ANDA 065046

HIKMA FARMACEUTICA

FDA Drug Application

Application #065046

Application Sponsors

ANDA 065046

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 7.5GM BASE/VIAL

0

CEFUROXIME SODIUM

CEFUROXIME SODIUM

FDA Submissions

	ORIG	1	AP	2004-01-09
LABELING; Labeling	SUPPL	3	AP	2008-08-25
LABELING; Labeling	SUPPL	9	AP	2016-05-06	STANDARD
LABELING; Labeling	SUPPL	11	AP	2019-11-16	STANDARD
LABELING; Labeling	SUPPL	12	AP	2021-07-07	STANDARD
LABELING; Labeling	SUPPL	13	AP	2021-07-07	STANDARD

Submissions Property Types

SUPPL	9	Null	15
SUPPL	11	Null	31
SUPPL	12	Null	15
SUPPL	13	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65046
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 7.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 7.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)