Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063206
Company: XGEN PHARMS
Company: XGEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMPHOTERICIN B | AMPHOTERICIN B | 50MG/VIAL | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/29/1992 | 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 |
|---|---|---|---|---|---|
| 03/05/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/17/2009 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 02/11/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/19/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/15/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 01/17/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |