Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040194
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1997 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/040194ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/10/2026 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2025 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2025 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2025 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/12/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/12/2001 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/23/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
METHYLPREDNISOLONE
TABLET;ORAL; 4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MEDROL | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | Yes | AB | 011153 | PFIZER |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 040189 | JUBILANT CADISTA |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 040183 | PH HEALTH |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 040194 | SANDOZ |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 204072 | TIANJIN TIANYAO |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 040232 | WATSON LABS |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Prescription | No | AB | 206751 | ZYDUS PHARMS |