NDA 021516

BAUSCH AND LOMB

FDA Drug Application

Application #021516

Documents

• Letter: 2004-06-10
• Label: 2004-06-10
• Label: 2013-06-17
• Review: 2006-01-31
• Letter: 2013-06-19

Application Sponsors

NDA 021516

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.5% BASE

1

ISTALOL

TIMOLOL MALEATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-06-04	STANDARD
LABELING; Labeling	SUPPL	5	AP	2013-06-17	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2012-11-15	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	5	Null	6
SUPPL	7	Null	0

TE Codes

001

Prescription

AT2

CDER Filings

BAUSCH AND LOMB

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(
    [0] => Array
        (
            [ApplNo] => 21516
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISTALOL","activeIngredients":"TIMOLOL MALEATE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/17\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021516s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21516_istalol_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ISTALOL","submission":"TIMOLOL MALEATE","actionType":"EQ 0.5% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-06-17
        )

)