NDA 010599

ABBVIE

FDA Drug Application

Application #010599

Application Sponsors

NDA 010599

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

TRAL

HEXOCYCLIUM METHYLSULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1957-02-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	1980-10-07
LABELING; Labeling	SUPPL	11	AP	1980-10-07
LABELING; Labeling	SUPPL	12	AP	1980-10-07
LABELING; Labeling	SUPPL	14	AP	1988-04-14

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10599
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRAL","activeIngredients":"HEXOCYCLIUM METHYLSULFATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRAL","submission":"HEXOCYCLIUM METHYLSULFATE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)