ANDA 209096

LUPIN LTD

FDA Drug Application

Application #209096

Application Sponsors

ANDA 209096

LUPIN LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	250MG	0	METRONIDAZOLE	METRONIDAZOLE
002	TABLET;ORAL	500MG	0	METRONIDAZOLE	METRONIDAZOLE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-09-12	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-08-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-03-31	STANDARD

Submissions Property Types

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

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

LUPIN LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209096
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METRONIDAZOLE","activeIngredients":"METRONIDAZOLE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/29\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-07-29
        )

)