ANDA 075358

BAUSCH AND LOMB

FDA Drug Application

Application #075358

Documents

• Label: 2004-05-26
• Letter: 2000-03-29
• Review: 2000-03-29

Application Sponsors

ANDA 075358

BAUSCH AND LOMB

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;INHALATION

EQ 0.083% BASE

0

ALBUTEROL SULFATE

ALBUTEROL SULFATE

FDA Submissions

	ORIG	1	AP	2000-03-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-01-22
LABELING; Labeling	SUPPL	3	AP	2001-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-07-23
LABELING; Labeling	SUPPL	12	AP	2004-05-14
LABELING; Labeling	SUPPL	14	AP	2004-09-21

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75358
            [companyName] => BAUSCH AND LOMB
            [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] => [{"actionDate":"03\/29\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2000\\\/75-358_Albuterol%20Sulfate_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 0.083% BASE","submissionClassification":"SOLUTION;INHALATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-03-29
        )

)