ANDA 205658

MAYNE PHARMA INC

FDA Drug Application

Application #205658

Application Sponsors

ANDA 205658

MAYNE PHARMA INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML;60MG/5ML

0

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-11-17

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205658
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"5MG\/5ML;60MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-17
        )

)