ANDA 209692

AMNEAL PHARMS

FDA Drug Application

Application #209692

Application Sponsors

ANDA 209692

AMNEAL PHARMS

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

UNKNOWN;

ORIG

1

AP

2018-11-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

AMNEAL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209692
            [companyName] => AMNEAL PHARMS
            [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":"11\/01\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-01
        )

)