NDA 019443

ABBOTT

FDA Drug Application

Application #019443

Application Sponsors

NDA 019443

ABBOTT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	0.9MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SODIUM BICARBONATE IN PLASTIC CONTAINER	SODIUM BICARBONATE
002	INJECTABLE;INJECTION	1MEQ/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SODIUM BICARBONATE IN PLASTIC CONTAINER	SODIUM BICARBONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

1986-06-03

STANDARD

CDER Filings

ABBOTT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19443
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM BICARBONATE IN PLASTIC CONTAINER","activeIngredients":"SODIUM BICARBONATE","strength":"0.9MEQ\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SODIUM BICARBONATE IN PLASTIC CONTAINER","activeIngredients":"SODIUM BICARBONATE","strength":"1MEQ\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM BICARBONATE IN PLASTIC CONTAINER","submission":"SODIUM BICARBONATE","actionType":"0.9MEQ\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SODIUM BICARBONATE IN PLASTIC CONTAINER","submission":"SODIUM BICARBONATE","actionType":"1MEQ\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)