ANDA 072128

PLIVA

FDA Drug Application

Application #072128

Application Sponsors

ANDA 072128

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

METHYLDOPA

METHYLDOPA

FDA Submissions

	ORIG	1	AP	1988-07-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-06-26
LABELING; Labeling	SUPPL	3	AP	1990-12-18
LABELING; Labeling	SUPPL	4	AP	1992-04-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1993-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-05-05
LABELING; Labeling	SUPPL	8	AP	1993-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-05-11
LABELING; Labeling	SUPPL	10	AP	1996-06-10
LABELING; Labeling	SUPPL	11	AP	1998-06-12

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72128
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLDOPA","activeIngredients":"METHYLDOPA","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLDOPA","submission":"METHYLDOPA","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)