NDA 018605

PHARMACIA AND UPJOHN

FDA Drug Application

Application #018605

Application Sponsors

NDA 018605

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

250MG/5ML

0

AZULFIDINE

SULFASALAZINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1980-12-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	1981-07-21
LABELING; Labeling	SUPPL	6	AP	1985-02-05
LABELING; Labeling	SUPPL	9	AP	1983-12-19
LABELING; Labeling	SUPPL	10	AP	1990-07-18

CDER Filings

PHARMACIA AND UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18605
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZULFIDINE","activeIngredients":"SULFASALAZINE","strength":"250MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZULFIDINE","submission":"SULFASALAZINE","actionType":"250MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)