ANDA 065306

ACS DOBFAR

FDA Drug Application

Application #065306

Application Sponsors

ANDA 065306

ACS DOBFAR

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	0	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM
002	INJECTABLE;INJECTION	EQ 20GM BASE/VIAL	0	CEFAZOLIN SODIUM	CEFAZOLIN SODIUM

FDA Submissions

	ORIG	1	AP	2008-10-22
LABELING; Labeling	SUPPL	2	AP	2011-05-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-08-18
LABELING; Labeling	SUPPL	4	AP	2013-02-13
LABELING; Labeling	SUPPL	6	AP	2014-12-02	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	15
SUPPL	6	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ACS DOBFAR

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65306
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CEFAZOLIN SODIUM","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 20GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFAZOLIN SODIUM","submission":"CEFAZOLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CEFAZOLIN SODIUM","submission":"CEFAZOLIN SODIUM","actionType":"EQ 20GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)