FERTIN PHARMA FDA Approval ANDA 214354

ANDA 214354

FERTIN PHARMA

FDA Drug Application

Application #214354

Application Sponsors

ANDA 214354FERTIN PHARMA

Marketing Status

Over-the-counter001

Application Products

001GUM, CHEWING;BUCCALEQ 4MG BASE0NICOTINE POLACRILEXNICOTINE POLACRILEX

FDA Submissions

UNKNOWN; ORIG1AP2022-12-21STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

FERTIN PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214354
            [companyName] => FERTIN PHARMA
            [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
        )

)

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