NDA 018509

MALLINCKRODT INC

FDA Drug Application

Application #018509

Application Sponsors

NDA 018509

MALLINCKRODT INC

Marketing Status

• Discontinued: 001

Application Products

001

GRANULE, EFFERVESCENT;ORAL

460MG/GM;420MG/GM

0

BAROS

SODIUM BICARBONATE; TARTARIC ACID

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1985-08-07	STANDARD
LABELING; Labeling	SUPPL	3	AP	1992-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1994-01-06	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0

CDER Filings

MALLINCKRODT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18509
            [companyName] => MALLINCKRODT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BAROS","activeIngredients":"SODIUM BICARBONATE; TARTARIC ACID","strength":"460MG\/GM;420MG\/GM","dosageForm":"GRANULE, EFFERVESCENT;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BAROS","submission":"SODIUM BICARBONATE; TARTARIC ACID","actionType":"460MG\/GM;420MG\/GM","submissionClassification":"GRANULE, EFFERVESCENT;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)