ANDA 065143

HIKMA FARMACEUTICA

FDA Drug Application

Application #065143

Application Sponsors

ANDA 065143

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10GM BASE/VIAL

0

CEFAZOLIN SODIUM

CEFAZOLIN SODIUM

FDA Submissions

	ORIG	1	AP	2004-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2012-01-11

Submissions Property Types

SUPPL

8

Null

15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65143
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFAZOLIN SODIUM","submission":"CEFAZOLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)