Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060570
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUNGIZONE | AMPHOTERICIN B | 3% | LOTION;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 |
|---|---|---|---|---|---|---|---|
| 11/12/1964 | 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 |
|---|---|---|---|---|---|
| 10/06/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/29/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/11/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/03/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1983 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/14/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |