L PERRIGO CO FDA Approval ANDA 076776

ANDA 076776

L PERRIGO CO

FDA Drug Application

Application #076776

Documents

Review2007-07-06

Application Sponsors

ANDA 076776L 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; LabelingSUPPL14AP2010-06-17
LABELING; LabelingSUPPL17AP2012-11-29STANDARD

Submissions Property Types

SUPPL17Null15

CDER Filings

L PERRIGO CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76776
            [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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