DR REDDYS LABS LTD FDA Approval ANDA 079043

ANDA 079043

DR REDDYS LABS LTD

FDA Drug Application

Application #079043

Documents

Letter2011-06-29

Application Sponsors

ANDA 079043DR REDDYS LABS LTD

Marketing Status

Over-the-counter002

Application Products

002TABLET, EXTENDED RELEASE;ORAL180MG;240MG0FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

ORIG1AP2010-03-17
LABELING; LabelingSUPPL3AP2011-06-22
LABELING; LabelingSUPPL5AP2016-01-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2022-05-17UNKNOWN

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL5Null15
SUPPL6Null7

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79043
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"180MG;240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE","submission":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"180MG;240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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