ANDA 207393

LUPIN LTD

FDA Drug Application

Application #207393

Application Sponsors

ANDA 207393

LUPIN LTD

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	CAPSULE;ORAL	18MG	0	DICLOFENAC	DICLOFENAC
002	CAPSULE;ORAL	35MG	0	DICLOFENAC	DICLOFENAC

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-12-02

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207393
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICLOFENAC","activeIngredients":"DICLOFENAC","strength":"18MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"DICLOFENAC","activeIngredients":"DICLOFENAC","strength":"35MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-12-02
        )

)