ANDA 071279

AM REGENT

FDA Drug Application

Application #071279

Application Sponsors

ANDA 071279

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

METHYLDOPATE HYDROCHLORIDE

METHYLDOPATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1987-12-02
LABELING; Labeling	SUPPL	4	AP	1992-03-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1995-03-20
LABELING; Labeling	SUPPL	6	AP	1994-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-02-28
LABELING; Labeling	SUPPL	8	AP	1996-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-01-29
LABELING; Labeling	SUPPL	10	AP	1998-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-09-05

Submissions Property Types

SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71279
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLDOPATE HYDROCHLORIDE","activeIngredients":"METHYLDOPATE HYDROCHLORIDE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLDOPATE HYDROCHLORIDE","submission":"METHYLDOPATE HYDROCHLORIDE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)