HAVIX FDA Approval ANDA 214088

ANDA 214088

HAVIX

FDA Drug Application

Application #214088

Application Sponsors

ANDA 214088HAVIX

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL25MG;325MG0BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITAL
002TABLET;ORAL50MG;325MG0BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITAL
003TABLET;ORAL50MG;300MG0BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITAL

FDA Submissions

UNKNOWN; ORIG1AP2022-04-07STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA
002PrescriptionAA
003PrescriptionAA

CDER Filings

HAVIX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214088
            [companyName] => HAVIX
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"25MG;325MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUTALBITAL AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"50MG;325MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BUTALBITAL AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"50MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-07
        )

)

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