RHODES PHARMS FDA Approval ANDA 208756

ANDA 208756

RHODES PHARMS

FDA Drug Application

Application #208756

Application Sponsors

ANDA 208756RHODES PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL2.5MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
002TABLET;ORAL5MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE
003TABLET;ORAL10MG0DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-11-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

RHODES PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208756
            [companyName] => RHODES PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXMETHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"DEXMETHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/20\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-11-20
        )

)

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