NDA 021493

ALLERGAN

FDA Drug Application

Application #021493

Documents

• Letter: 2005-06-21
• Letter: 2015-05-22
• Label: 2005-06-21
• Letter: 2003-04-01
• Letter: 2005-06-21
• Label: 2003-04-01
• Label: 2005-06-21
• Label: 2015-05-27
• Review: 2005-05-02
• Label: 2017-03-22
• Letter: 2017-03-24
• Pediatric Medical Review: 2009-05-19
• Pediatric Clinical Pharmacology Review: 2009-05-19
• Pediatric Statistical Review: 2009-05-19
• Pediatric Written Request: 2009-05-19
• Pediatric Amendment 4: 2009-05-19
• Pediatric Medical Review: 2017-03-21

Application Sponsors

NDA 021493

ALLERGAN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.3%

1

ZYMAR

GATIFLOXACIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2003-03-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2004-07-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2005-06-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2005-06-20	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2017-03-21	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2015-05-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	2017-03-21	STANDARD

Submissions Property Types

SUPPL	6	Null	0
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21493
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYMAR","activeIngredients":"GATIFLOXACIN","strength":"0.3%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/21\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021493s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2015","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021493s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2005","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021493s006,007lbl.pdf\"}]","notes":""},{"actionDate":"06\/20\/2005","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021493s006,007lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21493_Zymar_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZYMAR","submission":"GATIFLOXACIN","actionType":"0.3%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-03-21
        )

)