ANDA 075416

ACTAVIS LABS FL INC

FDA Drug Application

Application #075416

Documents

• Review: 2014-08-01

Application Sponsors

ANDA 075416

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 500MG BASE	0	NAPROXEN SODIUM	NAPROXEN SODIUM
002	TABLET, EXTENDED RELEASE;ORAL	EQ 375MG BASE	0	NAPROXEN SODIUM	NAPROXEN SODIUM
003	TABLET, EXTENDED RELEASE;ORAL	EQ 750MG BASE	0	NAPROXEN SODIUM	NAPROXEN SODIUM

FDA Submissions

	ORIG	1	AP	2002-08-27
LABELING; Labeling	SUPPL	2	AP	2003-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2003-04-23
LABELING; Labeling	SUPPL	6	AP	2007-04-03
LABELING; Labeling	SUPPL	8	AP	2008-02-21
LABELING; Labeling	SUPPL	12	AP	2015-04-15	STANDARD
LABELING; Labeling	SUPPL	16	AP	2016-09-08	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-11-25	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	12	Null	7
SUPPL	16	Null	31
SUPPL	19	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75416
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 500MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 375MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"NAPROXEN SODIUM","activeIngredients":"NAPROXEN SODIUM","strength":"EQ 750MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 500MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 375MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"NAPROXEN SODIUM","submission":"NAPROXEN SODIUM","actionType":"EQ 750MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)