ANDA 074072

PLIVA

FDA Drug Application

Application #074072

Application Sponsors

ANDA 074072

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

AEROSOL, METERED;INHALATION

0.09MG/INH

0

ALBUTEROL

ALBUTEROL

FDA Submissions

	ORIG	1	AP	1996-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-01-20
LABELING; Labeling	SUPPL	4	AP	1998-05-08
LABELING; Labeling	SUPPL	5	AP	1998-12-03
LABELING; Labeling	SUPPL	6	AP	1999-07-13
LABELING; Labeling	SUPPL	7	AP	1999-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-08-23

Submissions Property Types

SUPPL	1	Null	1
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74072
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL","activeIngredients":"ALBUTEROL","strength":"0.09MG\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL","submission":"ALBUTEROL","actionType":"0.09MG\/INH","submissionClassification":"AEROSOL, METERED;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)