ANDA 084214

IMPAX LABS

FDA Drug Application

Application #084214

Application Sponsors

ANDA 084214

IMPAX LABS

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

25MG

0

PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1974-08-14
LABELING; Labeling	SUPPL	28	AP	2001-01-23
LABELING; Labeling	SUPPL	29	AP	1991-08-16
LABELING; Labeling	SUPPL	30	AP	1996-05-30
LABELING; Labeling	SUPPL	32	AP	1997-03-27
LABELING; Labeling	SUPPL	33	AP	1997-03-27

Submissions Property Types

SUPPL	30	Null	1
SUPPL	32	Null	1
SUPPL	33	Null	1

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84214
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG","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"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)