NDA 050589

ASTELLAS

FDA Drug Application

Application #050589

Documents

• Letter: 2005-01-21

Application Sponsors

NDA 050589

ASTELLAS

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 20MG BASE/ML	0	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFTIZOXIME SODIUM
002	INJECTABLE;INJECTION	EQ 40MG BASE/ML	0	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFTIZOXIME SODIUM
003	INJECTABLE;INJECTION	EQ 20MG BASE/ML	0	CEFIZOX IN PLASTIC CONTAINER	CEFTIZOXIME SODIUM
004	INJECTABLE;INJECTION	EQ 40MG BASE/ML	0	CEFIZOX IN PLASTIC CONTAINER	CEFTIZOXIME SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1984-10-03	STANDARD
LABELING; Labeling	SUPPL	2	AP	1985-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-02-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1992-02-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	2009-03-13
LABELING; Labeling	SUPPL	6	AP	1992-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-02-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-04-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	1992-09-25
LABELING; Labeling	SUPPL	11	AP	1993-05-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-02-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2005-01-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50589
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"CEFTIZOXIME SODIUM","strength":"EQ 20MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"CEFTIZOXIME SODIUM","strength":"EQ 40MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFIZOX IN PLASTIC CONTAINER","activeIngredients":"CEFTIZOXIME SODIUM","strength":"EQ 20MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFIZOX IN PLASTIC CONTAINER","activeIngredients":"CEFTIZOXIME SODIUM","strength":"EQ 40MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"CEFTIZOXIME SODIUM","actionType":"EQ 20MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER","submission":"CEFTIZOXIME SODIUM","actionType":"EQ 40MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFIZOX IN PLASTIC CONTAINER","submission":"CEFTIZOXIME SODIUM","actionType":"EQ 20MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFIZOX IN PLASTIC CONTAINER","submission":"CEFTIZOXIME SODIUM","actionType":"EQ 40MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)