ANDA 064134

BAUSCH AND LOMB

FDA Drug Application

Application #064134

Documents

• Letter: 1999-10-27
• Label: 2004-06-28
• Review: 2002-01-17

Application Sponsors

ANDA 064134

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.1%;0.3%

0

TOBRAMYCIN AND DEXAMETHASONE

DEXAMETHASONE; TOBRAMYCIN

FDA Submissions

	ORIG	1	AP	1999-10-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-11-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-02-05
LABELING; Labeling	SUPPL	9	AP	2008-11-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH AND LOMB

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(
    [0] => Array
        (
            [ApplNo] => 64134
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOBRAMYCIN AND DEXAMETHASONE","activeIngredients":"DEXAMETHASONE; TOBRAMYCIN","strength":"0.1%;0.3%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/27\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/99\\\/64-134_Tobramycin%20and%20Dexamethasone_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TOBRAMYCIN AND DEXAMETHASONE","submission":"DEXAMETHASONE; TOBRAMYCIN","actionType":"0.1%;0.3%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1999-10-27
        )

)