ANDA 070820

AM REGENT

FDA Drug Application

Application #070820

Application Sponsors

ANDA 070820

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

80MG/ML

0

DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-02-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-02-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-06-30
LABELING; Labeling	SUPPL	4	AP	1992-08-26
LABELING; Labeling	SUPPL	5	AP	1992-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-02-28
LABELING; Labeling	SUPPL	8	AP	1996-09-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-01-09
LABELING; Labeling	SUPPL	10	AP	1997-11-07
LABELING; Labeling	SUPPL	11	AP	2001-11-07
LABELING; Labeling	SUPPL	17	AP	2021-06-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	17	Null	15

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70820
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOPAMINE HYDROCHLORIDE","activeIngredients":"DOPAMINE HYDROCHLORIDE","strength":"80MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DOPAMINE HYDROCHLORIDE","submission":"DOPAMINE HYDROCHLORIDE","actionType":"80MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)