ANDA 214955

AACE PHARMS

FDA Drug Application

Application #214955

Application Sponsors

ANDA 214955

AACE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG;300MG

0

BUTALBITAL AND ACETAMINOPHEN

ACETAMINOPHEN; BUTALBITAL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-08-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

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
        )

)