ANDA 209306

LUPIN LTD

FDA Drug Application

Application #209306

Application Sponsors

ANDA 209306

LUPIN LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	600MG	0	GABAPENTIN	GABAPENTIN
002	TABLET;ORAL	800MG	0	GABAPENTIN	GABAPENTIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-08-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-11-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-11-12	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	7

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209306
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GABAPENTIN","activeIngredients":"GABAPENTIN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-24
        )

)