Application Sponsors
ANDA 207667 | AUROBINDO PHARMA LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
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 2GM BASE/VIAL | 0 | METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-12-15 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2020-04-02 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
004 | Prescription | AP |
CDER Filings
AUROBINDO PHARMA LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 207667
[companyName] => AUROBINDO PHARMA LTD
[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 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/15\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/02\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/02\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-02
)
)