ACCORD HLTHCARE FDA Approval ANDA 214726

ANDA 214726

ACCORD HLTHCARE

FDA Drug Application

Application #214726

Application Sponsors

ANDA 214726ACCORD HLTHCARE

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001CAPSULE;ORALEQ 30MG BASE0OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE
002CAPSULE;ORALEQ 45MG BASE0OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE
003CAPSULE;ORALEQ 75MG BASE0OSELTAMIVIR PHOSPHATEOSELTAMIVIR PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-25STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ACCORD HLTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214726
            [companyName] => ACCORD HLTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 30MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 45MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OSELTAMIVIR PHOSPHATE","activeIngredients":"OSELTAMIVIR PHOSPHATE","strength":"EQ 75MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OSELTAMIVIR PHOSPHATE","submission":"OSELTAMIVIR PHOSPHATE","actionType":"EQ 30MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OSELTAMIVIR PHOSPHATE","submission":"OSELTAMIVIR PHOSPHATE","actionType":"EQ 45MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OSELTAMIVIR PHOSPHATE","submission":"OSELTAMIVIR PHOSPHATE","actionType":"EQ 75MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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