DR REDDYS LABS LTD FDA Approval ANDA 215932

ANDA 215932

DR REDDYS LABS LTD

FDA Drug Application

Application #215932

Application Sponsors

ANDA 215932DR REDDYS LABS LTD

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001TABLET, EXTENDED RELEASE;ORAL600MG0GUAIFENESINGUAIFENESIN
002TABLET, EXTENDED RELEASE;ORAL1.2GM0GUAIFENESINGUAIFENESIN

FDA Submissions

UNKNOWN; ORIG1AP2022-03-15STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215932
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"GUAIFENESIN","activeIngredients":"GUAIFENESIN","strength":"600MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"},{"drugName":"GUAIFENESIN","activeIngredients":"GUAIFENESIN","strength":"1.2GM","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-15
        )

)

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