ANDA 210817

MAYNE PHARMA INC

FDA Drug Application

Application #210817

Application Sponsors

ANDA 210817

MAYNE PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

300MG;50MG;40MG

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210817
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"300MG;50MG;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-17
        )

)