Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060517
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FUNGIZONE | AMPHOTERICIN B | 50MG/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/01/1966 | 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 |
|---|---|---|---|---|---|
| 11/07/2002 | SUPPL-24 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/07/2002 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/07/2002 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 11/07/2002 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 11/16/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 09/25/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/09/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/24/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 03/31/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 05/20/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |