ANDA 040471

MYLAN INSTITUTIONAL

FDA Drug Application

Application #040471

Application Sponsors

ANDA 040471

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

25MG/ML

0

PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-11-21
LABELING; Labeling	SUPPL	7	AP	2005-06-24

Submissions Property Types

ORIG

1

Null

1

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40471
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROMETHAZINE HYDROCHLORIDE","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROMETHAZINE HYDROCHLORIDE","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)