ANDA 207313

MAYNE PHARMA INC

FDA Drug Application

Application #207313

Application Sponsors

ANDA 207313

MAYNE PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

300MG;50MG

0

BUTALBITAL AND ACETAMINOPHEN

ACETAMINOPHEN; BUTALBITAL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-27

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207313
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; BUTALBITAL","strength":"300MG;50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-27
        )

)