Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050341
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUNGIZONE | AMPHOTERICIN B | 100MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 06/02/1971 | 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 |
|---|---|---|---|---|---|
| 01/17/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1996 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/24/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |