NOVITIUM PHARMA FDA Approval ANDA 210971

ANDA 210971

NOVITIUM PHARMA

FDA Drug Application

Application #210971

Application Sponsors

ANDA 210971NOVITIUM PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 1MG BASE0PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDE
002CAPSULE;ORALEQ 2MG BASE0PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDE
003CAPSULE;ORALEQ 5MG BASE0PRAZOSIN HYDROCHLORIDEPRAZOSIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-10-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

NOVITIUM PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210971
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRAZOSIN HYDROCHLORIDE","activeIngredients":"PRAZOSIN HYDROCHLORIDE","strength":"EQ 1MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAZOSIN HYDROCHLORIDE","activeIngredients":"PRAZOSIN HYDROCHLORIDE","strength":"EQ 2MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PRAZOSIN HYDROCHLORIDE","activeIngredients":"PRAZOSIN HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/03\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-03
        )

)

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