Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061392
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 250MG BASE | CAPSULE;ORAL | Discontinued | None | No | No |
| PRINCIPEN | AMPICILLIN/AMPICILLIN TRIHYDRATE | EQ 500MG 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 |
|---|---|---|---|---|---|---|---|
| 03/03/1971 | 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 |
|---|---|---|---|---|---|
| 02/20/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/29/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |