SAGENT PHARMS INC FDA Approval ANDA 040888

ANDA 040888

SAGENT PHARMS INC

FDA Drug Application

Application #040888

Application Sponsors

ANDA 040888SAGENT PHARMS INC

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

ORIG1AP2011-07-18
LABELING; LabelingSUPPL3AP2020-02-14STANDARD
LABELING; LabelingSUPPL4AP2020-02-14STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL4Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP
004PrescriptionAP
005PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40888
            [companyName] => SAGENT PHARMS INC
            [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":"METHYLPREDNISOLONE SODIUM SUCCINATE","submission":"METHYLPREDNISOLONE SODIUM SUCCINATE","actionType":"EQ 40MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPREDNISOLONE SODIUM SUCCINATE","submission":"METHYLPREDNISOLONE SODIUM SUCCINATE","actionType":"EQ 125MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPREDNISOLONE SODIUM SUCCINATE","submission":"METHYLPREDNISOLONE SODIUM SUCCINATE","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPREDNISOLONE SODIUM SUCCINATE","submission":"METHYLPREDNISOLONE SODIUM SUCCINATE","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPREDNISOLONE SODIUM SUCCINATE","submission":"METHYLPREDNISOLONE SODIUM SUCCINATE","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.