L PERRIGO CO FDA Approval ANDA 076775

ANDA 076775

L PERRIGO CO

FDA Drug Application

Application #076775

Documents

Review2007-07-06
Review2014-08-05

Application Sponsors

ANDA 076775L PERRIGO CO

Marketing Status

Over-the-counter001

Application Products

001GUM, CHEWING;BUCCALEQ 2MG BASE0NICOTINE POLACRILEXNICOTINE POLACRILEX

FDA Submissions

ORIG1AP2004-09-16
LABELING; LabelingSUPPL2AP2005-08-15
LABELING; LabelingSUPPL16AP2010-06-17
LABELING; LabelingSUPPL18AP2011-08-30
LABELING; LabelingSUPPL21AP2012-11-29STANDARD
LABELING; LabelingSUPPL22AP2015-04-15STANDARD
LABELING; LabelingSUPPL24AP2019-11-01STANDARD

Submissions Property Types

SUPPL18Null15
SUPPL21Null15
SUPPL22Null15
SUPPL24Null7

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
        )

)

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