NDA 022428

NOVARTIS

FDA Drug Application

Application #022428

Documents

• Letter: 2010-11-26
• Letter: 2012-09-18
• Review: 2011-06-07
• Summary Review: 2011-06-07
• Letter: 2011-10-20
• Label: 2010-11-26
• Label: 2012-09-18
• Label: 2017-02-21
• Letter: 2017-02-23
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2021-08-12
• Letter: 2021-08-12

Application Sponsors

NDA 022428

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

EQ 0.5% BASE

1

MOXEZA

MOXIFLOXACIN HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2010-11-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2012-09-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-02-17	STANDARD
LABELING; Labeling	SUPPL	10	AP	2021-08-11	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	15
SUPPL	9	Null	6
SUPPL	10	Null	6

TE Codes

001

Prescription

AT2

CDER Filings

IMPRIMIS PHARMS USA

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            [ApplNo] => 22428
            [companyName] => IMPRIMIS PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MOXEZA","activeIngredients":"MOXIFLOXACIN HYDROCHLORIDE","strength":"EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/11\/2021","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022428s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022428s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022428s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022428s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022428s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MOXEZA","submission":"MOXIFLOXACIN HYDROCHLORIDE","actionType":"EQ 0.5% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-08-11
        )

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