Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050314
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUNGIZONE | AMPHOTERICIN B | 3% | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/07/1966 | 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 |
|---|---|---|---|---|---|
| 06/13/1996 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/24/1978 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1978 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/28/1975 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1971 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/07/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |