Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040196
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET;ORAL | Discontinued | None | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET;ORAL | Discontinued | None | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET;ORAL | Discontinued | None | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Discontinued | None | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Discontinued | None | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1997 | 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 |
|---|---|---|---|---|---|
| 04/15/2002 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/15/2002 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/15/2002 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-4 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 02/23/2000 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/08/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |