Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060624
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OMNIPEN (AMPICILLIN) | AMPICILLIN/AMPICILLIN TRIHYDRATE | 250MG | CAPSULE;ORAL | Discontinued | None | No | No |
| OMNIPEN (AMPICILLIN) | AMPICILLIN/AMPICILLIN TRIHYDRATE | 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 |
|---|---|---|---|---|---|---|---|
| 12/17/1965 | 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 |
|---|---|---|---|---|---|
| 08/13/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |