Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018459
Company: XANODYNE PHARM
Company: XANODYNE PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEUCOVORIN CALCIUM | LEUCOVORIN CALCIUM | EQ 5MG BASE | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/08/1980 | 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 |
|---|---|---|---|---|---|
| 10/09/2001 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/25/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/21/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/30/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 11/05/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |