AACE PHARMS FDA Approval ANDA 214955

ANDA 214955

AACE PHARMS

FDA Drug Application

Application #214955

Application Sponsors

ANDA 214955AACE PHARMS

Marketing Status

Prescription001

Application Products

001TABLET;ORAL50MG;300MG0BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITAL

FDA Submissions

UNKNOWN; ORIG1AP2022-08-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

AACE PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214955
            [companyName] => AACE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"50MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-16
        )

)

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