NDA 022548

ALLERGAN

FDA Drug Application

Application #022548

Documents

• Letter: 2010-05-21
• Summary Review: 2011-02-17
• Label: 2010-05-28
• Review: 2010-12-08
• Label: 2016-09-08
• Letter: 2016-09-12
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Review: 2023-01-17

Application Sponsors

NDA 022548

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

1

ZYMAXID

GATIFLOXACIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2010-05-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	2016-09-08	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15

TE Codes

001

Prescription

AT

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22548
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYMAXID","activeIngredients":"GATIFLOXACIN","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/08\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022548s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022548s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZYMAXID","submission":"GATIFLOXACIN","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-09-08
        )

)