TARO PHARM INDS LTD FDA Approval ANDA 213046

ANDA 213046

TARO PHARM INDS LTD

FDA Drug Application

Application #213046

Application Sponsors

ANDA 213046TARO PHARM INDS LTD

Marketing Status

Prescription001

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2020-07-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

TARO PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213046
            [companyName] => TARO PHARM INDS LTD
            [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":"07\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-01
        )

)

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