ANDA 061806

GLAXOSMITHKLINE

FDA Drug Application

Application #061806

Application Sponsors

ANDA 061806

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	EQ 250MG BASE	0	CLOXAPEN	CLOXACILLIN SODIUM
002	CAPSULE;ORAL	EQ 500MG BASE	0	CLOXAPEN	CLOXACILLIN SODIUM

FDA Submissions

ORIG

1

AP

1974-09-17

Submissions Property Types

ORIG

1

Null

29

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61806
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOXAPEN","activeIngredients":"CLOXACILLIN SODIUM","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLOXAPEN","activeIngredients":"CLOXACILLIN SODIUM","strength":"EQ 500MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOXAPEN","submission":"CLOXACILLIN SODIUM","actionType":"EQ 250MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CLOXAPEN","submission":"CLOXACILLIN SODIUM","actionType":"EQ 500MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)