Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062728
Company: ABRAXIS PHARM
Company: ABRAXIS PHARM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMPHOTERICIN B | 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 |
---|---|---|---|---|---|---|---|
04/13/1987 | 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 |
---|---|---|---|---|---|
10/20/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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04/07/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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06/25/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |