ANDA 200791

INVAGEN PHARMS

FDA Drug Application

Application #200791

Application Sponsors

ANDA 200791

INVAGEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

25MG

0

MECLIZINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2022-02-17

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

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
        )

)