BEXIMCO PHARMS USA FDA Approval ANDA 081127

ANDA 081127

BEXIMCO PHARMS USA

FDA Drug Application

Application #081127

Application Sponsors

ANDA 081127BEXIMCO PHARMS USA

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORALEQ 25MG HYDROCHLORIDE0HYDROXYZINE PAMOATEHYDROXYZINE PAMOATE

FDA Submissions

ORIG1AP1991-06-28

Submissions Property Types

SUPPL1Null0

CDER Filings

BEXIMCO PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81127
            [companyName] => BEXIMCO PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROXYZINE PAMOATE","activeIngredients":"HYDROXYZINE PAMOATE","strength":"EQ 25MG HYDROCHLORIDE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROXYZINE PAMOATE","submission":"HYDROXYZINE PAMOATE","actionType":"EQ 25MG HYDROCHLORIDE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.