ANDA 091009

ACTAVIS LABS FL

FDA Drug Application

Application #091009

Application Sponsors

ANDA 091009

ACTAVIS LABS FL

Marketing Status

• Over-the-counter: 002

Application Products

002

TABLET, EXTENDED RELEASE;ORAL

1.2GM

0

GUAIFENESIN

GUAIFENESIN

FDA Submissions

ORIG

1

AP

2015-09-03

Submissions Property Types

ORIG

1

Null

19

CDER Filings

ACTAVIS LABS FL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91009
            [companyName] => ACTAVIS LABS FL
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUAIFENESIN","activeIngredients":"GUAIFENESIN","strength":"1.2GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GUAIFENESIN","submission":"GUAIFENESIN","actionType":"1.2GM","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)