GENEYORK PHARMS FDA Approval ANDA 212396

ANDA 212396

GENEYORK PHARMS

FDA Drug Application

Application #212396

Application Sponsors

ANDA 212396GENEYORK PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001INJECTABLE;INJECTIONEQ 40MG BASE/VIAL0METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATE
002INJECTABLE;INJECTIONEQ 125MG BASE/VIAL0METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATE
003INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATE
004INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATE
005INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP
005PrescriptionAP

CDER Filings

GENEYORK PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212396
            [companyName] => GENEYORK PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE SODIUM SUCCINATE","activeIngredients":"METHYLPREDNISOLONE SODIUM SUCCINATE","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE SODIUM SUCCINATE","activeIngredients":"METHYLPREDNISOLONE SODIUM SUCCINATE","strength":"EQ 125MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE SODIUM SUCCINATE","activeIngredients":"METHYLPREDNISOLONE SODIUM SUCCINATE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE SODIUM SUCCINATE","activeIngredients":"METHYLPREDNISOLONE SODIUM SUCCINATE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE SODIUM SUCCINATE","activeIngredients":"METHYLPREDNISOLONE SODIUM SUCCINATE","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-20
        )

)

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