ABBVIE FDA Approval ANDA 040117

ANDA 040117

ABBVIE

FDA Drug Application

Application #040117

Application Sponsors

ANDA 040117ABBVIE

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL660MG;10MG0VICODIN HPACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

ORIG1AP1996-09-23
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2001-05-01

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40117
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VICODIN HP","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"660MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VICODIN HP","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"660MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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