ANDA 085146

INVATECH

FDA Drug Application

Application #085146

Application Sponsors

ANDA 085146

INVATECH

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	25MG	0	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE
002	TABLET;ORAL	50MG	0	PROMETHAZINE HYDROCHLORIDE	PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1994-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1983-04-05

Submissions Property Types

SUPPL

5

Null

0

CDER Filings

INVATECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85146
            [companyName] => INVATECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)