Application Sponsors
ANDA 212396 | GENEYORK PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
Prescription | 005 |
Application Products
001 | INJECTABLE;INJECTION | EQ 40MG BASE/VIAL | 0 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE |
002 | INJECTABLE;INJECTION | EQ 125MG BASE/VIAL | 0 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE |
003 | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | 0 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE |
004 | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | 0 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE |
005 | INJECTABLE;INJECTION | EQ 2GM BASE/VIAL | 0 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-04-20 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
004 | Prescription | AP |
005 | Prescription | AP |
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
)
)