ANDA 063182

MYLAN INSTITUTIONAL

FDA Drug Application

Application #063182

Application Sponsors

ANDA 063182

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 20MG BASE/ML	0	MEFOXIN IN PLASTIC CONTAINER	CEFOXITIN SODIUM
002	INJECTABLE;INJECTION	EQ 40MG BASE/ML	0	MEFOXIN IN PLASTIC CONTAINER	CEFOXITIN SODIUM

FDA Submissions

	ORIG	1	AP	1993-01-25
LABELING; Labeling	SUPPL	2	AP	1996-02-26
LABELING; Labeling	SUPPL	3	AP	1998-04-04
LABELING; Labeling	SUPPL	4	AP	1996-07-29
LABELING; Labeling	SUPPL	5	AP	1995-05-31
LABELING; Labeling	SUPPL	6	AP	2002-08-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-06-04
LABELING; Labeling	SUPPL	11	AP	2004-12-06
LABELING; Labeling	SUPPL	12	AP	2004-02-06
LABELING; Labeling	SUPPL	13	AP	2004-11-05
LABELING; Labeling	SUPPL	14	AP	2008-01-31
LABELING; Labeling	SUPPL	15	AP	2009-02-12
LABELING; Labeling	SUPPL	18	AP	2017-03-07

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	18	Null	15

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 63182
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEFOXIN IN PLASTIC CONTAINER","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 20MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MEFOXIN IN PLASTIC CONTAINER","activeIngredients":"CEFOXITIN SODIUM","strength":"EQ 40MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEFOXIN IN PLASTIC CONTAINER","submission":"CEFOXITIN SODIUM","actionType":"EQ 20MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MEFOXIN IN PLASTIC CONTAINER","submission":"CEFOXITIN SODIUM","actionType":"EQ 40MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)