ANDA 040515

AM REGENT

FDA Drug Application

Application #040515

Application Sponsors

ANDA 040515

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

25MG/ML

0

PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2003-03-19
LABELING; Labeling	SUPPL	2	AP	2005-06-21
LABELING; Labeling	SUPPL	3	AP	2006-03-13
LABELING; Labeling	SUPPL	7	AP	2009-11-19

Submissions Property Types

ORIG	1	Null	1
SUPPL	7	Null	7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40515
            [companyName] => AM REGENT
            [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
        )

)