Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062323
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POLYMOX | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| POLYMOX | AMOXICILLIN | 250MG/5ML | FOR SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 12/08/1981 | ORIG-1 | Approval |
Label is not available on this site. |