GRANULES FDA Approval ANDA 216082

ANDA 216082

GRANULES

FDA Drug Application

Application #216082

Application Sponsors

ANDA 216082GRANULES

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001TABLET, EXTENDED RELEASE;ORAL600MG;60MG0GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL1.2GM;120MG0GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEGUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-08-22STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

GRANULES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216082
            [companyName] => GRANULES
            [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":"08\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-22
        )

)

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