ANDA 078314

GLENMARK PHARMS LTD

FDA Drug Application

Application #078314

Documents

• Other Important Information from FDA: 2007-05-08

Application Sponsors

ANDA 078314

GLENMARK PHARMS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	EQ 250MG BASE	0	NAPROXEN SODIUM	NAPROXEN SODIUM
002	TABLET;ORAL	EQ 500MG BASE	0	NAPROXEN SODIUM	NAPROXEN SODIUM

FDA Submissions

	ORIG	1	AP	2007-04-27
LABELING; Labeling	SUPPL	2	AP	2008-09-08
LABELING; Labeling	SUPPL	5	AP	2015-03-02	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-07-28	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-07-28	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-07-28	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	6	Null	7
SUPPL	8	Null	7
SUPPL	12	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

GLENMARK PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78314
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)