Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040415
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
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 | 3MG | 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 | 6MG | 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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/27/2004 | 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 |
---|---|---|---|---|---|
02/28/2012 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
11/22/2011 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
02/08/2011 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
08/04/2010 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
11/16/2009 | SUPPL-8 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
01/22/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/09/2007 | SUPPL-3 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/040415s003lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/09/2007 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/040415s003lbl.pdf |