NDA 022211

BAUSCH AND LOMB

FDA Drug Application

Application #022211

Documents

• Letter: 2009-09-21
• Label: 2009-09-21
• Review: 2010-01-05
• Summary Review: 2010-01-05

Application Sponsors

NDA 022211

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

GEL;OPHTHALMIC

0.15%

1

ZIRGAN

GANCICLOVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2009-09-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2014-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2014-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2014-05-12

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22211
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIRGAN","activeIngredients":"GANCICLOVIR","strength":"0.15%","dosageForm":"GEL;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/15\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022211lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZIRGAN","submission":"GANCICLOVIR","actionType":"0.15%","submissionClassification":"GEL;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2009-09-15
        )

)