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. |
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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. |
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01/12/1971 | SUPPL-7 | Labeling |
Label is not available on this site. |
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05/07/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |