ANDA 214088

HAVIX

FDA Drug Application

Application #214088

Application Sponsors

ANDA 214088

HAVIX

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	25MG;325MG	0	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL
002	TABLET;ORAL	50MG;325MG	0	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL
003	TABLET;ORAL	50MG;300MG	0	BUTALBITAL AND ACETAMINOPHEN	ACETAMINOPHEN; BUTALBITAL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-04-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA

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
        )

)