ANDA 061334

GLAXOSMITHKLINE

FDA Drug Application

Application #061334

Application Sponsors

ANDA 061334

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 006
• Discontinued: 007
• Discontinued: 008
• Discontinued: 009
• Discontinued: 010

Application Products

006	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	BACTOCILL	OXACILLIN SODIUM
007	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	BACTOCILL	OXACILLIN SODIUM
008	INJECTABLE;INJECTION	EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	BACTOCILL	OXACILLIN SODIUM
009	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	BACTOCILL	OXACILLIN SODIUM
010	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	BACTOCILL	OXACILLIN SODIUM

FDA Submissions

ORIG

1

AP

1982-03-26

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 61334
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACTOCILL","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BACTOCILL","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BACTOCILL","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 4GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BACTOCILL","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 500MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BACTOCILL","activeIngredients":"OXACILLIN SODIUM","strength":"EQ 10GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BACTOCILL","submission":"OXACILLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BACTOCILL","submission":"OXACILLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BACTOCILL","submission":"OXACILLIN SODIUM","actionType":"EQ 4GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BACTOCILL","submission":"OXACILLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BACTOCILL","submission":"OXACILLIN SODIUM","actionType":"EQ 10GM BASE\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)