NDA 050560

ASTELLAS

FDA Drug Application

Application #050560

Documents

• Letter: 2005-01-21

Application Sponsors

NDA 050560

ASTELLAS

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	CEFIZOX	CEFTIZOXIME SODIUM
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	CEFIZOX	CEFTIZOXIME SODIUM
003	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	CEFIZOX	CEFTIZOXIME SODIUM
005	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	0	CEFIZOX	CEFTIZOXIME SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1983-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1987-04-29	STANDARD
EFFICACY; Efficacy	SUPPL	36	AP	1992-06-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1989-05-05	STANDARD
LABELING; Labeling	SUPPL	43	AP	1992-01-22	STANDARD
LABELING; Labeling	SUPPL	46	AP	1993-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1995-07-10	STANDARD
LABELING; Labeling	SUPPL	49	AP	1995-12-14	STANDARD
LABELING; Labeling	SUPPL	50	AP	1996-02-13	STANDARD
LABELING; Labeling	SUPPL	51	AP	2005-01-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2000-08-07	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	33	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	43	Null	0
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50560
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEFIZOX","activeIngredients":"CEFTIZOXIME SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFIZOX","activeIngredients":"CEFTIZOXIME SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFIZOX","activeIngredients":"CEFTIZOXIME SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CEFIZOX","activeIngredients":"CEFTIZOXIME SODIUM","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEFIZOX","submission":"CEFTIZOXIME SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFIZOX","submission":"CEFTIZOXIME SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFIZOX","submission":"CEFTIZOXIME SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CEFIZOX","submission":"CEFTIZOXIME SODIUM","actionType":"EQ 10GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)