ANDA 073533

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #073533

Application Sponsors

ANDA 073533

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

EQ 0.083% BASE

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

	ORIG	1	AP	1995-09-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-07-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1999-07-16
LABELING; Labeling	SUPPL	8	AP	1998-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-08-17
LABELING; Labeling	SUPPL	13	AP	2000-08-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-01-25

Submissions Property Types

SUPPL	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	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73533
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.083% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 0.083% BASE","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)