ANDA 091071

ACTAVIS LABS FL

FDA Drug Application

Application #091071

Documents

• Letter: 2015-06-02

Application Sponsors

ANDA 091071

ACTAVIS LABS FL

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	0	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	0	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2015-05-27

Submissions Property Types

ORIG

1

Null

19

CDER Filings

ACTAVIS LABS FL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91071
            [companyName] => ACTAVIS LABS FL
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"600MG;60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"1.2GM;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE","submission":"GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"600MG;60MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"},{"actionDate":"GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE","submission":"GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"1.2GM;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)