Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040145
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 | 4MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | AB | No | No |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/26/1997 | 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 |
|---|---|---|---|---|---|
| 01/02/2020 | SUPPL-65 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2020 | SUPPL-64 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2020 | SUPPL-61 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/02/2020 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/27/2012 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/20/2010 | SUPPL-55 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/16/2010 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/15/2009 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 07/28/2008 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 01/08/2007 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 07/14/2003 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/06/2001 | SUPPL-41 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/22/2001 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/11/2000 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 09/18/2000 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/2000 | SUPPL-37 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/22/1999 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 03/07/2000 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-34 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/07/2000 | SUPPL-33 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/07/2000 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/18/2000 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/28/1999 | SUPPL-30 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/28/1999 | SUPPL-29 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/15/1999 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1999 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/15/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1999 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/24/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-15 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
WARFARIN SODIUM
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 | 040145 | BARR |
| WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | No | AB | 200104 | IPCA LABS LTD |
| 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 | 040145 | BARR |
| WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | No | AB | 200104 | IPCA LABS LTD |
| 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 | 040145 | BARR |
| 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 | 200104 | IPCA LABS LTD |
| 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; 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 | 040145 | BARR |
| WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | No | AB | 200104 | IPCA LABS LTD |
| 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 | 040145 | BARR |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | No | AB | 200104 | IPCA LABS LTD |
| 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; 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 | 040145 | BARR |
| 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 | 200104 | IPCA LABS LTD |
| 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 |
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 | 040145 | BARR |
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 10MG | TABLET;ORAL | Prescription | No | AB | 200104 | IPCA LABS LTD |
| 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; 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 | 040145 | BARR |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | No | AB | 200104 | IPCA LABS LTD |
| 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; 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 | 040145 | BARR |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | No | AB | 090935 | INVAGEN PHARMS |
| WARFARIN SODIUM | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | No | AB | 200104 | IPCA LABS LTD |
| 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 |