NDA 021199

SANTEN

FDA Drug Application

Application #021199

Documents

• Letter: 2000-08-18
• Letter: 2002-04-18
• Letter: 2005-04-12
• Letter: 2014-12-04
• Label: 2005-04-12
• Label: 2014-12-10
• Letter: 2002-06-04
• Letter: 2005-04-12
• Label: 2000-08-18
• Label: 2002-04-18
• Label: 2002-06-04
• Label: 2005-04-12
• Review: 2004-03-24

Application Sponsors

NDA 021199

SANTEN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

QUIXIN

LEVOFLOXACIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-08-18	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2002-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-06-04	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2005-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2005-04-11	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2014-12-03	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	14	Null	7

CDER Filings

SANTEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21199
            [companyName] => SANTEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUIXIN","activeIngredients":"LEVOFLOXACIN","strength":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/03\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021199s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2005","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021199s004,005lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2005","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021199s004,005lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2002","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21199s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2002","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21199s2lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21199lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"QUIXIN","submission":"LEVOFLOXACIN","actionType":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-12-03
        )

)