Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202691
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/16/2016 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/23/2019 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
12/23/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
METHYLPREDNISOLONE SODIUM SUCCINATE
INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202691 | HIKMA |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040888 | SAGENT PHARMS INC |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212396 | TIANJIN KINGYORK |
SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 011856 | PHARMACIA AND UPJOHN |
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040612 | FRESENIUS KABI USA |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 202691 | HIKMA |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040888 | SAGENT PHARMS INC |
METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 212396 | TIANJIN KINGYORK |
SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 011856 | PHARMACIA AND UPJOHN |