NDA 021571

SANTEN

FDA Drug Application

Application #021571

Documents

• Letter: 2004-03-02
• Label: 2014-12-10
• Review: 2004-10-26
• Letter: 2014-12-04
• Label: 2004-03-03

Application Sponsors

NDA 021571

SANTEN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

IQUIX

LEVOFLOXACIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-03-01	STANDARD
LABELING; Labeling	SUPPL	6	AP	2014-12-03	STANDARD

Submissions Property Types

SUPPL

6

Null

7

CDER Filings

SANTEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21571
            [companyName] => SANTEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"IQUIX","activeIngredients":"LEVOFLOXACIN","strength":"1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021571s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21571_iquix_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IQUIX","submission":"LEVOFLOXACIN","actionType":"1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":"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
        )

)