SUN PHARM FDA Approval ANDA 214781

ANDA 214781

SUN PHARM

FDA Drug Application

Application #214781

Application Sponsors

ANDA 214781SUN PHARM

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001TABLET, EXTENDED RELEASE;ORAL30MG;600MG0GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
002TABLET, EXTENDED RELEASE;ORAL60MG;1.2GM0GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

FDA Submissions

UNKNOWN; ORIG1AP2021-07-01STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

SUN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214781
            [companyName] => SUN PHARM
            [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":"07\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-01
        )

)

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