Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050729
Company: ALKOPHARMA USA
Company: ALKOPHARMA USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMPHOTEC | AMPHOTERICIN B | 50MG/VIAL | INJECTABLE, LIPID COMPLEX;INJECTION | Discontinued | None | No | No |
AMPHOTEC | AMPHOTERICIN B | 100MG/VIAL | INJECTABLE, LIPID COMPLEX;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 |
---|---|---|---|---|---|---|---|
11/22/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/27/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |