Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071962
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 10MG 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 |
|---|---|---|---|---|---|---|---|
| 11/19/1987 | 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 |
|---|---|---|---|---|---|
| 04/28/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/29/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 11/04/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/04/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/04/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |