ANDA 075050

BAUSCH AND LOMB

FDA Drug Application

Application #075050

Documents

• Letter: 1998-06-18

Application Sponsors

ANDA 075050

BAUSCH AND LOMB

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

EQ 0.5% BASE

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

	ORIG	1	AP	1998-06-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-04-28
LABELING; Labeling	SUPPL	4	AP	1999-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-11-27
LABELING; Labeling	SUPPL	17	AP	2017-03-31	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	17	Null	15

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75050
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 0.5% BASE","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)