MAYNE PHARMA INC FDA Approval ANDA 210817

ANDA 210817

MAYNE PHARMA INC

FDA Drug Application

Application #210817

Application Sponsors

ANDA 210817MAYNE PHARMA INC

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL300MG;50MG;40MG0BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

UNKNOWN; ORIG1AP2019-12-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

MAYNE PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210817
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"300MG;50MG;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-17
        )

)

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