INVAGEN PHARMS FDA Approval ANDA 200791

ANDA 200791

INVAGEN PHARMS

FDA Drug Application

Application #200791

Application Sponsors

ANDA 200791INVAGEN PHARMS

Marketing Status

Prescription001

Application Products

001TABLET, CHEWABLE;ORAL25MG0MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDE

FDA Submissions

N/A; Not ApplicableORIG1AP2022-02-17

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200791
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MECLIZINE HYDROCHLORIDE","activeIngredients":"MECLIZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MECLIZINE HYDROCHLORIDE","submission":"MECLIZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.