Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040301
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 07/15/1999 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40301_Warfarin%20Sodium_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40301ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40301_Warfarin.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/27/2019 | SUPPL-38 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/27/2019 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2019 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2016 | SUPPL-33 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/02/2016 | SUPPL-32 | Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/19/2012 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/27/2012 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/20/2010 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/12/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/13/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/25/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/15/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40301_Warfarin%20Sodium_Prntlbl.pdf |
WARFARIN SODIUM
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 040416 | UPSHER SMITH LABS |
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 202202 | AMNEAL PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 040616 | PLIVA |
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 040301 | TARO |
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 040663 | ZYDUS PHARMS USA |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | No | AB | 040416 | UPSHER SMITH LABS |
| WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | No | AB | 202202 | AMNEAL PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | No | AB | 040616 | PLIVA |
| WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | No | AB | 040301 | TARO |
| WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | No | AB | 040663 | ZYDUS PHARMS USA |
TABLET;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | No | AB | 040416 | UPSHER SMITH LABS |
| WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | No | AB | 202202 | AMNEAL PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | No | AB | 040616 | PLIVA |
| WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | No | AB | 040301 | TARO |
| WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | No | AB | 040663 | ZYDUS PHARMS USA |
TABLET;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Prescription | No | AB | 040416 | UPSHER SMITH LABS |
| WARFARIN SODIUM | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Prescription | No | AB | 202202 | AMNEAL PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Prescription | No | AB | 040616 | PLIVA |
| WARFARIN SODIUM | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Prescription | No | AB | 040301 | TARO |
| WARFARIN SODIUM | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Prescription | No | AB | 040663 | ZYDUS PHARMS USA |
TABLET;ORAL; 3MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | No | AB | 040416 | UPSHER SMITH LABS |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | No | AB | 202202 | AMNEAL PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | No | AB | 040616 | PLIVA |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | No | AB | 040301 | TARO |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | No | AB | 040663 | ZYDUS PHARMS USA |
TABLET;ORAL; 4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | No | AB | 040416 | UPSHER SMITH LABS |
| WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | No | AB | 202202 | AMNEAL PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | No | AB | 040616 | PLIVA |
| WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | No | AB | 040301 | TARO |
| WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | No | AB | 040663 | ZYDUS PHARMS USA |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 040416 | UPSHER SMITH LABS |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 202202 | AMNEAL PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 040616 | PLIVA |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 040301 | TARO |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 040663 | ZYDUS PHARMS USA |
TABLET;ORAL; 6MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | No | AB | 040416 | UPSHER SMITH LABS |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | No | AB | 202202 | AMNEAL PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | No | AB | 040616 | PLIVA |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | No | AB | 040301 | TARO |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | No | AB | 040663 | ZYDUS PHARMS USA |
TABLET;ORAL; 7.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 040416 | UPSHER SMITH LABS |
| WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 202202 | AMNEAL PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 040616 | PLIVA |
| WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 040301 | TARO |
| WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 040663 | ZYDUS PHARMS USA |