ANDA 091070

ACTAVIS LABS FL

FDA Drug Application

Application #091070

Documents

• Letter: 2015-09-04

Application Sponsors

ANDA 091070

ACTAVIS LABS FL

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	30MG;600MG	0	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
002	TABLET, EXTENDED RELEASE;ORAL	60MG;1.2GM	0	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

FDA Submissions

ORIG

1

AP

2015-08-31

Submissions Property Types

ORIG

1

Null

42

CDER Filings

ACTAVIS LABS FL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91070
            [companyName] => ACTAVIS LABS FL
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE","activeIngredients":"DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN","strength":"30MG;600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE","activeIngredients":"DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN","strength":"60MG;1.2GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE","submission":"DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN","actionType":"30MG;600MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE","submission":"DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN","actionType":"60MG;1.2GM","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)