Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040301
Company: TARO PHARM
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/14/2016 SUPPL-33 Labeling-Medication Guide, Labeling-Container/Carton Labels

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
COUMADIN WARFARIN SODIUM 10MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 10MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
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 PHARM
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
COUMADIN WARFARIN SODIUM 1MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 1MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
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 PHARM
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
COUMADIN WARFARIN SODIUM 2MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 2MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
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 PHARM
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
COUMADIN WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 2.5MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
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 PHARM
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
COUMADIN WARFARIN SODIUM 3MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 3MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
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 PHARM
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
COUMADIN WARFARIN SODIUM 4MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 4MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
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 PHARM
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
COUMADIN WARFARIN SODIUM 5MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 5MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
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 PHARM
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
COUMADIN WARFARIN SODIUM 6MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 6MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
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 PHARM
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
COUMADIN WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription Yes AB 009218 BRISTOL MYERS SQUIBB
JANTOVEN WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 040416 USL PHARMA
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 PHARM
WARFARIN SODIUM WARFARIN SODIUM 7.5MG TABLET;ORAL Prescription No AB 040663 ZYDUS PHARMS USA

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