ANDA 084233

INVATECH

FDA Drug Application

Application #084233

Application Sponsors

ANDA 084233

INVATECH

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

12.5MG

0

PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-02-08

Submissions Property Types

SUPPL	6	Null	0
SUPPL	8	Null	0

CDER Filings

INVATECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84233
            [companyName] => INVATECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)