Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083009
Company: SOLVAY
Company: SOLVAY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORASONE | PREDNISONE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| ORASONE | PREDNISONE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| ORASONE | PREDNISONE | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| ORASONE | PREDNISONE | 20MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/29/1974 | ORIG-1 | Approval |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/083009_orasone_toc.cfm |