ANDA 091353

GRANULES INDIA

FDA Drug Application

Application #091353

Application Sponsors

ANDA 091353

GRANULES INDIA

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

220MG

0

NAPROXEN SODIUM

NAPROXEN SODIUM

FDA Submissions

	ORIG	1	AP	2011-09-20
LABELING; Labeling	SUPPL	8	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2019-11-06	UNKNOWN
LABELING; Labeling	SUPPL	16	AP	2022-09-06	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-09-06	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-09-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	8	Null	7
SUPPL	10	Null	7
SUPPL	13	Null	15
SUPPL	15	Null	15
SUPPL	16	Null	7
SUPPL	19	Null	15
SUPPL	21	Null	15

CDER Filings

GRANULES INDIA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91353
            [companyName] => GRANULES INDIA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"220MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"220MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)