Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040145
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-Package Insert, Labeling-Medication Guide

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

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