Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209097
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 4MG | TABLET;ORAL | Discontinued | None | No | No |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 8MG | TABLET;ORAL | Discontinued | None | No | No |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 16MG | TABLET;ORAL | Discontinued | None | No | No |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | 32MG | TABLET;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 02/22/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/11/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |