YAOPHARMA CO LTD FDA Approval ANDA 070663

ANDA 070663

YAOPHARMA CO LTD

FDA Drug Application

Application #070663

Application Sponsors

ANDA 070663YAOPHARMA CO LTD

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL10MG0PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDE

FDA Submissions

ORIG1AP1986-06-13
LABELING; LabelingSUPPL2AP1986-11-19
LABELING; LabelingSUPPL3AP1986-12-18
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1988-12-22
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1988-12-22
LABELING; LabelingSUPPL6AP1988-12-22
LABELING; LabelingSUPPL7AP1987-07-31
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1988-02-11
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1988-12-22
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1988-12-22
LABELING; LabelingSUPPL11AP1988-11-29
LABELING; LabelingSUPPL12AP1989-07-10
LABELING; LabelingSUPPL13AP1992-05-22
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1995-05-18
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2001-05-09

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL5Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL14Null0
SUPPL15Null0

CDER Filings

YAOPHARMA CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70663
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE","activeIngredients":"PROPRANOLOL HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE","submission":"PROPRANOLOL HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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