MYLAN PHARMS INC FDA Approval ANDA 207825

ANDA 207825

MYLAN PHARMS INC

FDA Drug Application

Application #207825

Application Sponsors

ANDA 207825MYLAN PHARMS INC

Marketing Status

Prescription001

Application Products

001TABLET, DELAYED RELEASE;ORAL10MG;10MG0DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEDOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-06STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207825
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE","activeIngredients":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","strength":"10MG;10MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-06
        )

)

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