Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063099
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIMOX | AMOXICILLIN | 250MG | CAPSULE;ORAL | Discontinued | None | No | No |
| TRIMOX | AMOXICILLIN | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/20/1992 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/08/2002 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |