Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040557
Company: HONG KONG
Company: HONG KONG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | AB | No | No |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 02/23/2005 | 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 |
|---|---|---|---|---|---|
| 07/06/2022 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2020 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/03/2012 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
METHYLPREDNISOLONE ACETATE
INJECTABLE;INJECTION; 40MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 011757 | PFIZER |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 210043 | AMNEAL |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 216502 | AMNEAL |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 220556 | CAPLIN |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 211930 | EUGIA PHARMA |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040557 | HONG KONG |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 214297 | PH HEALTH |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 201835 | SAGENT PHARMS INC |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040719 | SANDOZ |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040794 | SANDOZ |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 40MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 214870 | WILSHIRE PHARMS INC |
INJECTABLE;INJECTION; 80MG/ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AB | 011757 | PFIZER |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 210043 | AMNEAL |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 216502 | AMNEAL |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 220556 | CAPLIN |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 211930 | EUGIA PHARMA |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 219145 | HIKMA |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040557 | HONG KONG |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 214297 | PH HEALTH |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 201835 | SAGENT PHARMS INC |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040719 | SANDOZ |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 040794 | SANDOZ |
| METHYLPREDNISOLONE ACETATE | METHYLPREDNISOLONE ACETATE | 80MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 214870 | WILSHIRE PHARMS INC |