ANDA 207386

MIKART

FDA Drug Application

Application #207386

Application Sponsors

ANDA 207386

MIKART

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

300MG;50MG

0

BUTALBITAL AND ACETAMINOPHEN

ACETAMINOPHEN; BUTALBITAL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-15

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207386
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"300MG;50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-15
        )

)