NDA 050683

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050683

Application Sponsors

NDA 050683

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	ZEFAZONE IN PLASTIC CONTAINER	CEFMETAZOLE SODIUM
002	INJECTABLE;INJECTION	EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	ZEFAZONE IN PLASTIC CONTAINER	CEFMETAZOLE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

1992-12-29

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

PHARMACIA AND UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50683
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZEFAZONE IN PLASTIC CONTAINER","activeIngredients":"CEFMETAZOLE SODIUM","strength":"EQ 20MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZEFAZONE IN PLASTIC CONTAINER","activeIngredients":"CEFMETAZOLE SODIUM","strength":"EQ 40MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZEFAZONE IN PLASTIC CONTAINER","submission":"CEFMETAZOLE SODIUM","actionType":"EQ 20MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZEFAZONE IN PLASTIC CONTAINER","submission":"CEFMETAZOLE SODIUM","actionType":"EQ 40MG BASE\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)