NDA 020569

BAUSCH AND LOMB

FDA Drug Application

Application #020569

Application Sponsors

NDA 020569

BAUSCH AND LOMB

Marketing Status

• Discontinued: 001

Application Products

001

IMPLANT;IMPLANTATION

4.5MG

0

VITRASERT

GANCICLOVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-03-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-08-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-04-18

Submissions Property Types

ORIG	1	Null	39
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20569
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"VITRASERT","activeIngredients":"GANCICLOVIR","strength":"4.5MG","dosageForm":"IMPLANT;IMPLANTATION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VITRASERT","submission":"GANCICLOVIR","actionType":"4.5MG","submissionClassification":"IMPLANT;IMPLANTATION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)