Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040416
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| JANTOVEN | WARFARIN SODIUM | 1MG | TABLET;ORAL | Prescription | AB | No | No |
| JANTOVEN | WARFARIN SODIUM | 2MG | TABLET;ORAL | Prescription | AB | No | No |
| JANTOVEN | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Prescription | AB | No | No |
| JANTOVEN | WARFARIN SODIUM | 3MG | TABLET;ORAL | Prescription | AB | No | No |
| JANTOVEN | WARFARIN SODIUM | 4MG | TABLET;ORAL | Prescription | AB | No | No |
| JANTOVEN | WARFARIN SODIUM | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| JANTOVEN | WARFARIN SODIUM | 6MG | TABLET;ORAL | Prescription | AB | No | No |
| JANTOVEN | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Prescription | AB | No | No |
| JANTOVEN | WARFARIN SODIUM | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/02/2003 | 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 |
|---|---|---|---|---|---|
| 09/20/2019 | SUPPL-33 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/20/2019 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-28 | 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-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/28/2008 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/11/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/12/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/05/2006 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/29/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
JANTOVEN
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; 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; 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; 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 |
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 |