ANDA 065047

HIKMA FARMACEUTICA

FDA Drug Application

Application #065047

Documents

• Review: 2004-12-08
• Letter: 2003-04-10

Application Sponsors

ANDA 065047

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM

FDA Submissions

ORIG

1

AP

2001-09-18

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65047
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFAZOLIN SODIUM","submission":"CEFAZOLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFAZOLIN SODIUM","submission":"CEFAZOLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)