ANDA 205657

MAYNE PHARMA INC

FDA Drug Application

Application #205657

Application Sponsors

ANDA 205657

MAYNE PHARMA INC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

4MG/5ML;5MG/5ML;60MG/5ML

0

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-08-03

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205657
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"4MG\/5ML;5MG\/5ML;60MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/03\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-08-03
        )

)