NOSTRUM LABS INC FDA Approval ANDA 078149

ANDA 078149

NOSTRUM LABS INC

FDA Drug Application

Application #078149

Application Sponsors

ANDA 078149NOSTRUM LABS INC

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL325MG;50MG;40MG0BUTALBITAL, ASPIRIN AND CAFFEINEASPIRIN; BUTALBITAL; CAFFEINE

FDA Submissions

ORIG1AP2007-06-13
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2008-03-20
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2008-03-20

Submissions Property Types

SUPPL2Null0
SUPPL3Null0

TE Codes

001PrescriptionAA

CDER Filings

NOSTRUM LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78149
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ASPIRIN AND CAFFEINE","activeIngredients":"ASPIRIN; BUTALBITAL; CAFFEINE","strength":"325MG;50MG;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL, ASPIRIN AND CAFFEINE","submission":"ASPIRIN; BUTALBITAL; CAFFEINE","actionType":"325MG;50MG;40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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