ANDA 065048

HIKMA FARMACEUTICA

FDA Drug Application

Application #065048

Application Sponsors

ANDA 065048

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 750MG BASE/VIAL	0	CEFUROXIME SODIUM	CEFUROXIME SODIUM
002	INJECTABLE;INJECTION	EQ 1.5GM BASE/VIAL	0	CEFUROXIME SODIUM	CEFUROXIME SODIUM
003	Injectable; Injection	1.5G/20ML	0	CEFUROXIME	CEFUROXIME
004	Injectable; Injection	1.5G/100ML	0	CEFUROXIME	CEFUROXIME

FDA Submissions

	ORIG	1	AP	2004-01-09
LABELING; Labeling	SUPPL	8	AP	2008-01-16
LABELING; Labeling	SUPPL	14	AP	2016-04-12	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-11-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-07-07	STANDARD
LABELING; Labeling	SUPPL	19	AP	2021-07-07	STANDARD

Submissions Property Types

SUPPL	14	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65048
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFUROXIME","activeIngredients":"CEFUROXIME","strength":"1.5G\/20ML","dosageForm":"Injectable; Injection","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CEFUROXIME","activeIngredients":"CEFUROXIME","strength":"1.5G\/100ML","dosageForm":"Injectable; Injection","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 750MG BASE\/VIAL","dosageForm":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFUROXIME SODIUM","activeIngredients":"CEFUROXIME SODIUM","strength":"EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFUROXIME","submission":"CEFUROXIME","actionType":"1.5G\/20ML","submissionClassification":"Injectable; Injection","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFUROXIME","submission":"CEFUROXIME","actionType":"1.5G\/100ML","submissionClassification":"Injectable; Injection","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 750MG BASE\/VIAL","submissionClassification":"INJECTABLE;INTRAMUSCULAR, INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFUROXIME SODIUM","submission":"CEFUROXIME SODIUM","actionType":"EQ 1.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)