INVAGEN PHARMS FDA Approval ANDA 200432

ANDA 200432

INVAGEN PHARMS

FDA Drug Application

Application #200432

Application Sponsors

ANDA 200432INVAGEN PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL12.5MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
002TABLET;ORAL25MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE
003TABLET;ORAL50MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE

FDA Submissions

N/A; Not ApplicableORIG1AP2022-02-17

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200432
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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