ZYDUS FDA Approval ANDA 214184

ANDA 214184

ZYDUS

FDA Drug Application

Application #214184

Application Sponsors

ANDA 214184ZYDUS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL225MG0PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
002CAPSULE, EXTENDED RELEASE;ORAL325MG0PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE
003CAPSULE, EXTENDED RELEASE;ORAL425MG0PROPAFENONE HYDROCHLORIDEPROPAFENONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214184
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"225MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"325MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"425MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-21
        )

)

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