ANDA 076775

L PERRIGO CO

FDA Drug Application

Application #076775

Documents

• Review: 2007-07-06
• Review: 2014-08-05

Application Sponsors

ANDA 076775

L PERRIGO CO

Marketing Status

• Over-the-counter: 001

Application Products

001

GUM, CHEWING;BUCCAL

EQ 2MG 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	16	AP	2010-06-17
LABELING; Labeling	SUPPL	18	AP	2011-08-30
LABELING; Labeling	SUPPL	21	AP	2012-11-29	STANDARD
LABELING; Labeling	SUPPL	22	AP	2015-04-15	STANDARD
LABELING; Labeling	SUPPL	24	AP	2019-11-01	STANDARD

Submissions Property Types

SUPPL	18	Null	15
SUPPL	21	Null	15
SUPPL	22	Null	15
SUPPL	24	Null	7

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76775
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"NICOTINE POLACRILEX","activeIngredients":"NICOTINE POLACRILEX","strength":"EQ 2MG 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 2MG BASE","submissionClassification":"GUM, CHEWING;BUCCAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)