UCB INC FDA Approval ANDA 040134

ANDA 040134

UCB INC

FDA Drug Application

Application #040134

Application Sponsors

ANDA 040134UCB INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL650MG;7.5MG0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

ORIG1AP1996-11-21

Submissions Property Types

ORIG1Null0

CDER Filings

UCB INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40134
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"650MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"650MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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