ANDA 202653

LUPIN LTD

FDA Drug Application

Application #202653

Documents

• Letter: 2013-08-29

Application Sponsors

ANDA 202653

LUPIN LTD

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

GATIFLOXACIN

GATIFLOXACIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-08-28
LABELING; Labeling	SUPPL	7	AP	2020-10-02	STANDARD

Submissions Property Types

ORIG	1	Null	19
SUPPL	7	Null	15

TE Codes

001

Prescription

AT

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202653
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GATIFLOXACIN","activeIngredients":"GATIFLOXACIN","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/28\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202653Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-08-28
        )

)