YAOPHARMA CO LTD FDA Approval ANDA 074478

ANDA 074478

YAOPHARMA CO LTD

FDA Drug Application

Application #074478

Application Sponsors

ANDA 074478YAOPHARMA CO LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORALEQ 5MG BASE0METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDE
002TABLET;ORALEQ 10MG BASE0METOCLOPRAMIDE HYDROCHLORIDEMETOCLOPRAMIDE HYDROCHLORIDE

FDA Submissions

ORIG1AP1995-10-05
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-11-21
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-05-20
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2002-05-20
LABELING; LabelingSUPPL5AP2002-11-25
LABELING; LabelingSUPPL6AP2003-02-25

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0

CDER Filings

YAOPHARMA CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74478
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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