ANDA 064124

ACS DOBFAR SPA

FDA Drug Application

Application #064124

Application Sponsors

ANDA 064124

ACS DOBFAR SPA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 7.5GM BASE/VIAL

0

CEFUROXIME SODIUM

CEFUROXIME SODIUM

FDA Submissions

	ORIG	1	AP	1997-05-30
LABELING; Labeling	SUPPL	3	AP	2004-09-30
LABELING; Labeling	SUPPL	5	AP	2007-01-31
LABELING; Labeling	SUPPL	6	AP	2007-06-20
LABELING; Labeling	SUPPL	7	AP	2007-11-16
LABELING; Labeling	SUPPL	8	AP	2008-07-31
LABELING; Labeling	SUPPL	18	AP	2021-10-08	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	18	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ACS DOBFAR SPA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64124
            [companyName] => ACS DOBFAR SPA
            [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
        )

)