NDA 050581

MERCK

FDA Drug Application

Application #050581

Documents

• Review: 2004-08-10

Application Sponsors

NDA 050581

MERCK

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOXITIN SODIUM
002	INJECTABLE;INJECTION	EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	CEFOXITIN SODIUM
003	INJECTABLE;INJECTION	EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOXITIN SODIUM
004	INJECTABLE;INJECTION	EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	CEFOXITIN SODIUM

FDA Submissions

S; Supplement

SUPPL

20

AP

1997-02-27

STANDARD

Submissions Property Types

SUPPL

20

Null

0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50581
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)