Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050313
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUNGIZONE | AMPHOTERICIN B | 3% | OINTMENT;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 |
|---|---|---|---|---|---|---|---|
| 10/13/1965 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/25/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/25/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 02/08/1979 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 02/13/1975 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/06/1973 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 11/26/1971 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/23/1971 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/12/1971 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 12/29/1970 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/16/1967 | SUPPL-2 | Labeling |
Label is not available on this site. |