ANDA 076778

L PERRIGO CO

FDA Drug Application

Application #076778

Documents

• Review: 2007-05-09

Application Sponsors

ANDA 076778

L PERRIGO CO

Marketing Status

• Over-the-counter: 001

Application Products

001

GUM, CHEWING;BUCCAL

EQ 4MG BASE

0

NICOTINE POLACRILEX

NICOTINE POLACRILEX

FDA Submissions

	ORIG	1	AP	2004-09-16
LABELING; Labeling	SUPPL	2	AP	2005-08-15
LABELING; Labeling	SUPPL	13	AP	2010-06-17
LABELING; Labeling	SUPPL	16	AP	2012-11-29	STANDARD

Submissions Property Types

SUPPL

16

Null

15

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76778
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICOTINE POLACRILEX","activeIngredients":"NICOTINE POLACRILEX","strength":"EQ 4MG BASE","dosageForm":"GUM, CHEWING;BUCCAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NICOTINE POLACRILEX","submission":"NICOTINE POLACRILEX","actionType":"EQ 4MG BASE","submissionClassification":"GUM, CHEWING;BUCCAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)