NDA 021243

PHARMACIA UPJOHN

FDA Drug Application

Application #021243

Documents

• Review: 2010-10-15
• Letter: 2022-11-17
• Label: 2022-11-17

Application Sponsors

NDA 021243

PHARMACIA UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

500MG

0

AZULFIDINE EN-TABS

SULFASALAZINE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2000-08-18

STANDARD

CDER Filings

PHARMACIA UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21243
            [companyName] => PHARMACIA UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZULFIDINE EN-TABS","activeIngredients":"SULFASALAZINE","strength":"500MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AZULFIDINE EN-TABS","submission":"SULFASALAZINE","actionType":"500MG","submissionClassification":"TABLET; ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)