ANDA 205217

LUPIN LTD

FDA Drug Application

Application #205217

Application Sponsors

ANDA 205217

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	150MG	0	LAMIVUDINE	LAMIVUDINE
002	TABLET;ORAL	300MG	0	LAMIVUDINE	LAMIVUDINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-12-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205217
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/18\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-12-18
        )

)