ANDA 072316

PLIVA

FDA Drug Application

Application #072316

Application Sponsors

ANDA 072316

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 2MG BASE

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

	ORIG	1	AP	1989-01-30
LABELING; Labeling	SUPPL	2	AP	1992-06-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-05-11
LABELING; Labeling	SUPPL	4	AP	1994-05-17
LABELING; Labeling	SUPPL	5	AP	1994-05-17
LABELING; Labeling	SUPPL	6	AP	1995-12-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-08-01
LABELING; Labeling	SUPPL	9	AP	1998-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-07-07

Submissions Property Types

SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72316
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)