Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 213437
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 30MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 45MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| OSELTAMIVIR PHOSPHATE | OSELTAMIVIR PHOSPHATE | EQ 75MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/22/2026 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |