ANDA 061773

ACS DOBFAR

FDA Drug Application

Application #061773

Application Sponsors

ANDA 061773

ACS DOBFAR

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	INJECTABLE;INJECTION	EQ 250MG BASE/VIAL	0	KEFZOL	CEFAZOLIN SODIUM
002	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	KEFZOL	CEFAZOLIN SODIUM
003	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	KEFZOL	CEFAZOLIN SODIUM
004	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	0	KEFZOL	CEFAZOLIN SODIUM
005	INJECTABLE;INJECTION	EQ 20GM BASE/VIAL	0	KEFZOL	CEFAZOLIN SODIUM

FDA Submissions

	ORIG	1	AP	1973-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1991-07-10
LABELING; Labeling	SUPPL	46	AP	1991-07-25
LABELING; Labeling	SUPPL	47	AP	1991-11-21
LABELING; Labeling	SUPPL	48	AP	1991-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1991-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1991-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1991-10-29
LABELING; Labeling	SUPPL	52	AP	1992-06-29
LABELING; Labeling	SUPPL	53	AP	1992-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1993-04-02
LABELING; Labeling	SUPPL	56	AP	1993-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1999-03-03
LABELING; Labeling	SUPPL	59	AP	1999-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	63	AP	2002-09-18
LABELING; Labeling	SUPPL	66	AP	2008-05-29

Submissions Property Types

ORIG	1	Null	42
SUPPL	45	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	54	Null	0
SUPPL	58	Null	0
SUPPL	63	Null	0

CDER Filings

ACS DOBFAR

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61773
            [companyName] => ACS DOBFAR
            [docInserts] => ["",""]
            [products] => [{"drugName":"KEFZOL","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 250MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KEFZOL","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KEFZOL","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KEFZOL","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KEFZOL","activeIngredients":"CEFAZOLIN SODIUM","strength":"EQ 20GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KEFZOL","submission":"CEFAZOLIN SODIUM","actionType":"EQ 250MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KEFZOL","submission":"CEFAZOLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KEFZOL","submission":"CEFAZOLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KEFZOL","submission":"CEFAZOLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KEFZOL","submission":"CEFAZOLIN SODIUM","actionType":"EQ 20GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)